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Progesterone sustained release vaginal gel

Manufactured by Merck Group
Sourced in Germany

Progesterone sustained-release vaginal gel is a laboratory product used to provide a controlled and gradual release of progesterone in a gel formulation. It is intended for use in research and development applications.

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5 protocols using progesterone sustained release vaginal gel

1

Luteal Phase Support in IVF

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Luteal phase support was applied in all women, commencing on the insemination day. It consisted of 200 mg/d progesterone soft capsules (Utrogestan; Besins, Brussels, Belgium) or 20 mg/d dydrogesterone (Duphaston; Abbott, Hoofddorp, The Netherlands) or 90 mg/d progesterone sustained-release vaginal gel (Merck Serono S.p.A., Darmstadt, Germany) for 14 days. A serum β-hCG assay was performed on the 14th day after insemination to assess whether pregnancy had occurred. If the result was positive, TVS was performed after 14–16 days, and luteal phase support would be maintained until 10 to 12 weeks of gestation.
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2

Standardized Ovarian Stimulation and IVF Procedure

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Female patients were subjected to a standardized ovarian stimulation regimen, with protracted down-regulation with gonadotrophin-releasing hormone agonist (GnRH-a) (Diphereline, lpsen, France), followed by daily use of recombinant follicle-stimulating hormone (Gonal-f, Merck Serono, Germany), which was based on the ovarian response. The ovarian response was monitored by three-dimensional ultrasonography and serum hormone levels, and daily doses of Gonal-f were adjusted for ovarian hyperstimulation. Final maturation of oocytes was induced by injecting recombinant Human Chorionic Gonadotropin (HCG, Merck, Darmstadt, Germany) at doses of 5000 to 10,000 IU when at least 60% of follicular diameters were ≥ 18 mm. Vaginal ultrasound-guided oocyte retrieval was performed after thirty-six hours. Routine IVF or ICSI, according to the sperm quality, was performed after oocyte retrieval. Luteal support was started on the day of oocyte retrieval by injecting 60 mg of progesterone (Xianju, Zhejiang, China) or via the intravaginal administration of 90 mg of a progesterone sustained-release vaginal gel (Merck Serono, Germany).
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3

Frozen Embryo Transfer Protocols

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In this study, all the embryos were vitrified. Frozen embryo transfer (FET) can be performed in the second menstrual cycle or later. Endometrial preparation protocols included the natural cycle, artificial cycle, induced ovulation cycle and downregulation + artificial cycle, which were mainly based on whether the patient’s ovulation was normal or not, and were also combined with the patient’s timing. The natural cycle was mainly used for women with regular menstrual cycles and spontaneous ovulation. Follicular development was monitored by transvaginal ultrasound, luteal-phase support was applied on the day of ovulation with oral dydrogesterone (2 times daily, 10 mg once) (Abbott Co. America) and intravaginal administration of 90 mg of a progesterone sustained-release vaginal gel (Merck Co. Germany), and 1-2 cleavage stage embryos were transferred 3 days later or 1 blastocyst was transferred 5 days later. The artificial/induced ovulation cycle for women with irregular menstrual cycles was done as previously reported (17 (link)). Downregulation + artificial protocols were used for women with endometriosis. GnRH agonist 3.75 mg was applied on the 2nd-3rd day of the menstrual cycle, and 28-30 days later, the endometrium was prepared with the artificial cycle. In women with clinical pregnancy, luteal-phase support was continued at least until 55 days after FET.
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4

Frozen Embryo Transfer Protocols

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Whole embryos were frozen. Endometrial preparation for FET was performed in natural cycles, artificial/induced ovulation cycles and downregulation + artificial cycles for women with regular menstrual cycles plus spontaneous ovulation, irregular menstrual cycles, and endometriosis, respectively. Follicle and endometrial scanning was performed by vaginal ultrasound, and one to two embryos or one blastocyst transplantation was performed using abdominal ultrasound after 3 or 5 days of endometrial development with luteosterone. Routine corpus luteum support, namely, oral DYG (2 times daily, 10 mg once) (Abbott Co. America) and intravaginal administration of 90 mg of a progesterone sustained-release vaginal gel (Merck Co. Germany), was given. If pregnancy occurred, corpus luteum support was continued at least until 55 days after transplantation. All data were obtained by reviewing our reproductive center’s medical records.
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5

Frozen Embryo Transfer: Endometrial Preparation

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Endometrial preparation for FET was achieved by NC or HRT programs. Ovulation in the NC program was determined by monitoring follicular development with transvaginal ultrasonography and hormone levels. The patients receiving HRT-FET cycles were treated with daily oral estradiol valerate tablets (Progynova, Bayer, Germany) starting on the second day of menstruation. When the endometrial thickness reached 7 mm or thicker, oral dydrogesterone (2 times daily, 10 mg once) (Abbott Co. USA) and intravaginal administration of 90 mg of a progesterone sustained-release vaginal gel (Merck Co. Germany) were given daily. One or two thawed embryos were transferred with ultrasound guidance on the third day (cleavage-stage embryo) or the fifth day (blastocyst) after ovulation or progesterone administration. All the patients received luteal support with progesterone after ET. If transvaginal ultrasound showed a gestational sac and embryonic heartbeat 1 month after ET, luteal support was continued until 2 months of gestational age.
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