Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Infertility

Treatments: Procedure: Embryo transfer; Drug: GnRH agonist; Drug: Progesterone; Drug: External Estradiol; Procedure: Serum Estradiol and Progesterone levels

Study type: Interventional

Funder types: Other

Identifiers

NCT02736032

12016

Details and patient eligibility

About

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.

Enrollment: 310 patients

Sex: Female

Ages: 20 to 35 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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310 participants in 2 patient groups

With GnRHa

Active Comparator group

Description:

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.

Treatment:

Procedure: Embryo transfer

Drug: External Estradiol

Procedure: Serum Estradiol and Progesterone levels

Drug: Progesterone

Drug: GnRH agonist

Without GnRHa

Active Comparator group

Description:

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.

Treatment:

Procedure: Embryo transfer

Drug: External Estradiol

Procedure: Serum Estradiol and Progesterone levels

Drug: Progesterone