Leuprolide acetate, a GnRH agonist (GnRHa), was given for pituitary downregulation. Participants were allowed to use oral contraceptives before administration of the GnRHa, if this was standard practice at the center. Patients received daily injections of either HP-hMG (Menopur®, Ferring Pharmaceuticals, Inc, Parsippany, NJ, USA) 225 IU (3 vials) subcutaneously (SC) or follitropin beta for injection (rFSH: Follistim®, Merck & Co Inc, Whitehouse Station, NJ, USA) 225 IU SC for a minimum of 5 days for ovarian stimulation. Human chorionic gonadotropin (hCG; Novarel®, Ferring Pharmaceuticals, Inc) was administered to trigger ovulation.
Follistim
Manufactured by Merck Group
Sourced in United States, Denmark
Follistim is a laboratory equipment product designed for research purposes. It is a follicle-stimulating hormone (FSH) that is used to stimulate the growth and development of ovarian follicles. Follistim is a synthetic version of the naturally occurring human FSH.
Automatically generated - may contain errors
Lab products found in correlation
Menopur, by Ferring (10 mentions)
Ganirelix acetate, by Merck Group (4 mentions)
Pregnyl, by Merck Group (4 mentions)
Novarel, by Ferring (3 mentions)
Albix, by Novozymes (2 mentions)
Ganirelix acetate, by Organon (2 mentions)
Leuprolide acetate, by Abbott (2 mentions)
Ganirelix, by Merck Group (2 mentions)
Icsi cumulase, by CooperSurgical (1 mentions)
Lupron, by Abbvie (1 mentions)
Gonal f, by Merck Group (1 mentions)
Recombinant human hyaluronan, by Novozymes (1 mentions)
Lupron, by Abbott (1 mentions)
Immulite, by Siemens (1 mentions)
17 protocols using follistim
1
Ovarian Stimulation for IVF using GnRH Agonist
2
Bovine Oocyte Maturation Protocol
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Bovine cumulus-oocyte complexes (COCs) were recovered from abattoir-derived ovaries by a commercial company (DeSoto Biosciences) and matured in a defined medium (Herrick et al. 2016a (link)) containing recombinant human EGF (50 ng/mL), recombinant human follicle-stimulating hormone (Follistim, Merck & Co., Inc; 0.1 IU/mL), recombinant human hyaluronan (0.125 mg/mL, Novozymes, Bagsvaerd, Denmark), and recombinant human albumin (2.5 mg/mL, AlbIX, Novozymes). Groups of 50 COCs were matured in 2 mL of medium in sealed tubes gassed with 5% CO2 in air and maintained at ~38.5°C in a portable incubator during overnight shipment to our laboratory.
3
ICSI Protocol for Infertile Couples
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Only couples with normal BMI and no history of smoking, excess drinking, or use of recreational drugs were included. All patients included were Caucasian and had comparable durations and indications of infertility. The average AMH of the female partner was 3.2 ± 3 ng/mL, the average FSH was 5.3 ± 4 IU/mL, and the average peak estradiol for ICSI stimulation was 3066.3 ± 1731 pg/mL.
A similar superovulation protocol was used for all couples. Patients were treated with daily gonadotropins (Follistim; Merck, Kenilworth, NJ, USA; Gonal-F; EMD-Serono, Geneva, Switzerland; and/or Menopur; Ferring Pharmaceuticals Inc, Parsippany, NJ, USA). Precocious ovulation was prevented by GnRH antagonist administration (Ganirelix acetate; Merck, Kenilworth, NJ, USA; or Cetrotide; EMD-Serono Inc., Rockland, MA, USA). The trigger for final oocyte maturation with human chorionic gonadotropin (Pregnyl, Merck) was administered when the two leading follicles reached a diameter of ≥ 17 mm [22 , 23 (link)]. Transvaginal oocyte retrieval was performed under conscious sedation 35–37 h after hCG administration.
Cumulus-corona cells were removed by exposure to medium containing 40 IU/mL hyaluronidase (Cumulase; Halozyme Therapeutics, Inc., San Diego, CA) [24 ] and incubated 1–2 h prior to ICSI.
A similar superovulation protocol was used for all couples. Patients were treated with daily gonadotropins (Follistim; Merck, Kenilworth, NJ, USA; Gonal-F; EMD-Serono, Geneva, Switzerland; and/or Menopur; Ferring Pharmaceuticals Inc, Parsippany, NJ, USA). Precocious ovulation was prevented by GnRH antagonist administration (Ganirelix acetate; Merck, Kenilworth, NJ, USA; or Cetrotide; EMD-Serono Inc., Rockland, MA, USA). The trigger for final oocyte maturation with human chorionic gonadotropin (Pregnyl, Merck) was administered when the two leading follicles reached a diameter of ≥ 17 mm [22 , 23 (link)]. Transvaginal oocyte retrieval was performed under conscious sedation 35–37 h after hCG administration.
Cumulus-corona cells were removed by exposure to medium containing 40 IU/mL hyaluronidase (Cumulase; Halozyme Therapeutics, Inc., San Diego, CA) [24 ] and incubated 1–2 h prior to ICSI.
4
IVF Protocols for Oocyte Retrieval and Embryo Transfer
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Protocols for COH, oocyte retrieval, IVF, and embryo transfer were conducted according to the previously outlined practice (25) . Briefly, the patients were treated with gonadotropins (Follistim, Merck; Gonal-F, EMD-Serono; and/or Menopur, Ferring) until criteria for pituitary suppression with a GnRH antagonist (0.25mg Ganirelix acetate, Organon) were met (26) . The hCG (Pregnyl, Merck), GnRH agonist trigger (leuprolide), or dual trigger (a combination of hCG and GnRH agonist, depending on physicians' preference) were used for final oocyte maturation when the two lead follicles reached a mean diameter >17 mm. Ultrasound-guided transvaginal oocyte retrieval after 35 hours after final oocyte maturation was performed based on our standard practice (26) . One day after retrieval, luteal progesterone supplementation with intramuscular progesterone commenced. Fresh embryo transfer was performed on day 3 or day 5 using a Wallace catheter (Marlow/Cooper Surgical). The number of embryos transferred was based on the patient's age, her previous cycles, and clinical criteria (27) .
5
Superovulation and Oocyte Retrieval Protocol
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Similar superovulation protocols were utilized for all couples. Patients were treated with gonadotropins daily (Follistim; Merck, Kenilworth, NJ, USA; Gonal-F; EMD Serono, Geneva, Switzerland; and/or Menopur; Ferring Pharmaceuticals Inc, Parsippany, NJ, USA). GnRH-antagonist (Ganirelix acetate; Merck, Kenilworth, NJ, USA; or Cetrotide; EMD Serono In. Rockland, MA, USA) was administered to prevent precocious ovulation. Human chorionic gonadotropin (hCG) (Pregnyl Merck) was administered to trigger final oocyte maturation when the two leading follicles reached a diameter of ≥17 mm. Ultrasound-guided transvaginal oocyte retrieval was performed under anesthesia 35–37 h after hCG trigger. A period of 2 h after retrieval, oocyte-cumulus-complexes were denuded by 40 IU/ml recombinant human hyaluronidase (ICSI Cumulase; Cooper Surgical, Inc, Trumbull, CT). Oocytes were then incubated 1–2 h prior to ICSI.
6
IVF Stimulation Protocols and Outcomes
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The IVF protocols included gonadotropin-releasing hormone (GnRH)-agonist suppression, GnRH antagonist with or without estrogen priming, and microdose flare with leuprolide acetate. The protocols were selected by physician’s preference, and these were described elsewhere (15 , 16 (link)). The treatment medications included recombinant follicle-stimulating hormone (FSH) alone or FSH in combination with human menopausal gonadotropin (Gonal-F, EMD Serono; Follistim, Merck; Menopur, Ferring Pharmaceuticals).
For antagonist protocols, GnRH antagonist (Ganirelix, Merck; Cetrotide, EMD Serono) was started when the lead follicle size reached 13–14 mm or estradiol level was >300 pg/mL. Trigger of final oocyte maturation was performed with either human chorionic gonadotropin (Pregnyl, Merck; Novarel, Ferring Pharmaceuticals) or GnRH agonist (leuprolide acetate, 1 mg; Abbott Laboratories) when three follicles reached at least 17–18 mm in mean diameter. Fertilization was performed by either intracytoplasmic sperm injection or conventional insemination and evaluated 16–18 hours later.
For antagonist protocols, GnRH antagonist (Ganirelix, Merck; Cetrotide, EMD Serono) was started when the lead follicle size reached 13–14 mm or estradiol level was >300 pg/mL. Trigger of final oocyte maturation was performed with either human chorionic gonadotropin (Pregnyl, Merck; Novarel, Ferring Pharmaceuticals) or GnRH agonist (leuprolide acetate, 1 mg; Abbott Laboratories) when three follicles reached at least 17–18 mm in mean diameter. Fertilization was performed by either intracytoplasmic sperm injection or conventional insemination and evaluated 16–18 hours later.
7
Elagolix vs. Ganirelix in Ovarian Stimulation
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All donors began their cycles with oral contraceptives for 10–14 days to lead into ovarian stimulation. Three days after discontinuing oral contraceptives, donors began daily injections of recombinant FSH (Follistim; Merck, NJ), with the initial dose ranging from 275–325 IU per day on the basis of age, FSH level, AMH level, and antral follicular count. On day 6 and then at 2–3 days intervals, serum testing of E2 and ultrasound monitoring were performed to guide recombinant FSH dosing. Once a 14-mm lead follicle was noted on ultrasound, 20 units per day of subcutaneous human chorionic gonadotropin were administered daily along with ovulation suppression; the study group received elagolix (200 mg PO QHS; Orilissa; AbbVie Inc., IL), and the historical control group received ganirelix (250 mcg, SC QHS; Merck, NJ). Elagolix or ganirelix was then discontinued 24 hours before the GnRH agonist trigger. Once follicular maturity was reached on the basis of follicular number, follicular size, and E2 levels, a GnRH agonist (4 mg SC; Lupron; AbbVie, IL) was then used to induce ovulation. Oocyte retrieval was performed 36 hours after the trigger.
8
Minimal/Mild Ovarian Stimulation for IVF
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IVF Cycle 1 and IVF Cycle 2 performed in the same participants used similar ovarian stimulation protocols. In brief in each cycle, after oral contraceptive pill pre-treatment for approximately 2–3 weeks and adequate suppression, minimal/mild ovarian stimulation was started with an extended regimen (from cycle day 3 until the day before triggering) of clomiphene citrate (50 mg/day orally) in conjunction with letrozole (2.5 mg/day orally) with low dose of gonadotropin (75 IU daily) injections (Follistim, Merck, White House Station, NJ, USA; or Gonal-F, EMD Serono, Rockland, MA, USA) starting on cycle days 4–7. Hypothalamic-pituitary suppression using gonadotropin releasing hormone antagonist was used to prevent ovulation. The final maturation of oocytes was induced by a gonadotropin releasing hormone agonist or by human chorionic gonadotropin trigger when the lead follicle was > 18 mm. Retrieved oocytes were fertilized by intra-cytoplasmic sperm injection as clinically indicated. All embryos were cultured until the cleavage stage and then vitrified to be transferred in subsequent FET cycle.
9
Controlled Ovarian Stimulation and Embryo Transfer
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Controlled ovarian stimulation (COS) was carried out to maximize follicular response while minimizing the risk of ovarian hyperstimulation syndrome. COS, hCG trigger, oocyte retrieval, embryo culture, and ET were performed per our standard protocols (18) . Gonadotropin doses were based on patient age, weight, antral follicle count, and previous response to stimulation, if any. After initiating COS with the use of gonadotropins (Follistim, Merck; Gonal-F, EMD-Serono; and/or Menopur, Ferring Pharmaceuticals), ovulation was suppressed with the use of 0.25 mg ganirelix acetate (Merck) or cetrotide (EMD-Serono).
hCG was used as the ovulation trigger based on a previously described sliding-scale protocol (15, 18) . In general, the hCG trigger was given when two lead follicles attained a mean diameter R17 mm. Oocyte retrieval was performed under conscious sedation with the use of transvaginal ultrasound guidance 35-37 hours after hCG administration. Intramuscular progesterone was started the day after oocyte retrieval. Choice of insemination or intracytoplasmic sperm injection was based on the male partner's semen analysis. Embryos were cultured with the use of in-house culture media, and embryo transfers were performed with the use of Wallace catheters (Smiths Medical) at $1 cm below the uterine depth identified at a prior trial transfer.
hCG was used as the ovulation trigger based on a previously described sliding-scale protocol (15, 18) . In general, the hCG trigger was given when two lead follicles attained a mean diameter R17 mm. Oocyte retrieval was performed under conscious sedation with the use of transvaginal ultrasound guidance 35-37 hours after hCG administration. Intramuscular progesterone was started the day after oocyte retrieval. Choice of insemination or intracytoplasmic sperm injection was based on the male partner's semen analysis. Embryos were cultured with the use of in-house culture media, and embryo transfers were performed with the use of Wallace catheters (Smiths Medical) at $1 cm below the uterine depth identified at a prior trial transfer.
10
Individualized Ovarian Stimulation Protocol
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Patients included were women who underwent oocyte retrieval and subsequent embryo transfer at a single site academic fertility center. For each stimulation, an individualized antagonist ovarian stimulation protocol was employed using follicle-stimulating hormone follitropin alfa (Gonal F; EMD Serono, Rockland, MA) or (Follistim; Merck, and Co.), and follicle-stimulating hormone/luteinizing hormone menotropin (Menopur; Ferring Pharmaceuticals, NJ). Antagonist cetrorelix acetate (Cetrotide; Freedom Fertility Pharmacy, Byfield, MA) was initiated when a lead follicle reached 13 mm. Oocyte trigger was performed with 3–10,000 units of chorionic gonadotropin (Novarel, Ferring Pharmaceuticals) or leuprolide 36 hours before oocyte retrieval when two or more follicles measured greater than 18 mm and in conjunction with appropriate estradiol values. Follicular number and size were obtained via transvaginal ultrasound during ovarian stimulation monitoring, and serum samples were collected via peripheral venipuncture taken within 1 hour of the ultrasound measurement. Transvaginal oocyte aspiration was performed under total intravenous sedation 36 hours post-trigger. The demographic data collected included age and the patient’s medical diagnosis.
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