Trial | NCT02736032  Report issue

Title

Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    progesterone leuprolide estradiol ...

  • Study Participants

    310
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.
Study Started
Mar 31
2016
Primary Completion
May 31
2018
Study Completion
May 31
2018
Last Update
May 17
2018

Procedure Embryo transfer

The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy

Procedure Serum Estradiol and Progesterone levels

Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation

Drug GnRH agonist

GnRH agonist given on day 21 of the cycle preceding the embryo transfer

  • Other names: Decapeptyl SR

Drug External Estradiol

Estradiol started on day1 of the cycle for endometrial prepartaion

  • Other names: estradiol valerate of Cycloprogenova tablets

Drug Progesterone

progesterone as luteal phase support start after endometrium is well prepared

  • Other names: Cyclogest vaginal suppositories

With GnRHa Active Comparator

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 Active Comparator

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.

Criteria 

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
No Results Posted