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

NCT ID: NCT02736032

Last Updated: 2018-05-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 310 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2018-05-31

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.

Conditions

Infertility

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

With GnRHa

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.

Group Type: ACTIVE_COMPARATOR

Embryo transfer

Intervention Type: PROCEDURE

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

Serum Estradiol and Progesterone levels

Intervention Type: PROCEDURE

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

GnRH agonist

Intervention Type: DRUG

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

External Estradiol

Intervention Type: DRUG

Estradiol started on day1 of the cycle for endometrial prepartaion

Progesterone

Intervention Type: DRUG

progesterone as luteal phase support start after endometrium is well prepared

Without GnRHa

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.

Group Type: ACTIVE_COMPARATOR

Embryo transfer

Intervention Type: PROCEDURE

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

Serum Estradiol and Progesterone levels

Intervention Type: PROCEDURE

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

External Estradiol

Intervention Type: DRUG

Estradiol started on day1 of the cycle for endometrial prepartaion

Progesterone

Intervention Type: DRUG

progesterone as luteal phase support start after endometrium is well prepared

Interventions

Embryo transfer

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

Intervention Type: PROCEDURE

Serum Estradiol and Progesterone levels

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

Intervention Type: PROCEDURE

GnRH agonist

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

Intervention Type: DRUG

External Estradiol

Estradiol started on day1 of the cycle for endometrial prepartaion

Intervention Type: DRUG

Progesterone

progesterone as luteal phase support start after endometrium is well prepared

Intervention Type: DRUG

Other Intervention Names

Decapeptyl SR; estradiol valerate of Cycloprogenova tablets; Cyclogest vaginal suppositories

Eligibility 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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nile Ivf Center, Cairo, Egypt

OTHER

Sponsor Role: collaborator

Kamal Shaeer center of infertility

UNKNOWN

Sponsor Role: collaborator

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Yasmin Ahmed Bassiouny

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eman K Shaeer, MD

Role: STUDY_DIRECTOR

Cairo University

Locations

IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)

Cairo, , Egypt

Kamal Shaeer center of infertility

Giza, , Egypt

Nile IVF center

Giza, , Egypt

Countries

Egypt

Other Identifiers

12016

Identifier Type: -

Identifier Source: org_study_id