Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
Phase 3
Completed
- Conditions
- Infertility
- Interventions
- Procedure: Embryo transferProcedure: Serum Estradiol and Progesterone levelsDrug: External Estradiol
- Registration Number
- NCT02736032
- Lead Sponsor
- Cairo University
- Brief Summary
Traditionally, the use of GnRH-a suppression was considered essential for adequate endometrial hormonal modulation in cryopreserved-thawed embryo transfer cycles. Several studies, however, have questioned its necessity for controlled endometrial preparation. Using a high dose of estradiol from day 1 of the cycle will suppress the gonadotroph, preventing folliculogenesis and excessive secretion of LH, allowing adequate endometrial preparation without GnRH-a.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 310
Inclusion Criteria
- 20-35 years
- BMI 20-30
- Regular menses.
- No PCOS, no endometriosis
- No uterine anomalies or lesions
- No severe male factor
- All grade 1 cleaved stage embryos
Exclusion Criteria
- Less than 20 or more than 35 years
- BMI less than 20 or more than 30
- Irregular cycles
- PCOS or endometriosis
- Uterine anomalies or lesions
- Severe male factor
- Poor quality embryos for transfer
- Severe
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description With GnRHa Embryo transfer Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. With GnRHa Serum Estradiol and Progesterone levels Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. With GnRHa External Estradiol Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. Without GnRHa Embryo transfer Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. Without GnRHa Serum Estradiol and Progesterone levels Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. Without GnRHa External Estradiol Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. With GnRHa GnRH agonist Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. With GnRHa Progesterone Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using GnRHa followed by external estradiol and progesterone. The GnRHa depot from will be given on day 21 of the preceding cycle, on day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol followed up on day 12 of the cycle, if the endometrium is less than 8 mm, till day 15 of the cycle estradiol will be increased to 8 mg/day until 8 mm or more. Then, serum estradiol and progesterone levels are collected, and progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later. Without GnRHa Progesterone Cryopreserved-thawed embryo transfer cycle, with endometrial preparation using external estradiol and progesterone only. On day 1 of the transfer cycle, the patient will receive 6 mg/ day of estradiol and followed up on day 12 of the cycle, if the endometrium did not reach 8 mm, till day 15 of the cycle the dose will be increased to 8 mg/day until the endometrium is 8 or more mm. When the endometrium is ready, serum estradiol and progesterone levels are collected, then progesterone 800 mg vaginal suppository will be added and embryo transfer performed 2 to 3 days later.
- Primary Outcome Measures
Name Time Method Clinical pregnancy rate 5 weeks after embryo transfer] the detection of intrauterine gestational sac with positive pulsations
Live birth rate 9 months Pregnancy ending with a live birth
- Secondary Outcome Measures
Name Time Method Chemical pregnancy rate 14 days after embryo transfer positive serum Beta HCG 14 days after embryo transfer
Implantation rate. 5 weeks after embryo transfer the ratio between the number of embryos transferred and the number of sacs
Estradiol and Progesterone levels on day of start of progesterone supplementation 12 to 20 days The serum levels of estradiol and progesterone before embryo transfer
Endometrial thickness on day of start of progesterone supplementation 12 to 20 days The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos
Number of days needed for adequate (> 8mm) endometrial thickness 12 to 20 days Number of days on external hormones to prepare endometrium
Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing. 12 to 20 days Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.
Ongoing pregnancy rate 3 months Pregnancy ongoing beyond 12 weeks gestation
Early miscarriage rate 3 months Pregnancy loss in the first 12 weeks gestation
Trial Locations
- Locations (3)
Nile IVF center
🇪🇬Giza, Egypt
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
🇪🇬Cairo, Egypt
Kamal Shaeer center of infertility
🇪🇬Giza, Egypt