Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles
- Conditions
- Infertility
- Interventions
- Biological: frozen Embryo transferDrug: 10,000U hCG injectionDrug: administration of 6 mg Estradiol valerate
- Registration Number
- NCT02251925
- Lead Sponsor
- Royan Institute
- Brief Summary
This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.
- Detailed Description
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a) In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 460
- Patients with regular mensturation cycles
- Age 20-37 years
- Patients who underwent long protocol
- Body mass index (BMI) ≤ 30 kg/m2
- Patients who will undergo frozen embryo transfer for the first time
- Oocyte or embryo donation cycles
- Uterine diseases or malformations
- Hyper prolactinemia
- Thyroid disorders
- Tuberculosis
- Recurrent abortion history
- Severe endometriosis
- Ovulation disorders
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Hormonally controlled cycle with GnRH-a GnRH agonist (Superfact) In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved. Hormonally controlled cycle with GnRH-a frozen Embryo transfer In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved. Hormonally controlled cycle without GnRH-a frozen Embryo transfer In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group. Natural cycle + hCG for ovulation induction frozen Embryo transfer In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage. Natural cycle frozen Embryo transfer In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos. Natural cycle + hCG for ovulation induction 10,000U hCG injection In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage. Hormonally controlled cycle without GnRH-a administration of 6 mg Estradiol valerate In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate 4 weeks The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
- Secondary Outcome Measures
Name Time Method miscarriage rate 12 weeks Evaluation the miscarriage rate in patients of each group 12 weeks after embryo transfer.
Implantation rate 4 weeks Evaluation the implantation rate in patients of each groups 4-6 weeks after frozen embryo transfer
chemical pregnancy rates 2 weeks Evaluation the chemical pregnancy rates in patients of each group 2 weeks after embryo transfer.
Ongoing pregnancy 12 weeks Evaluation the ongoing pregnancy in patients of each group 12 weeks after embryo transfer.
Trial Locations
- Locations (1)
Royan Institute
🇮🇷Tehran, Iran, Islamic Republic of