Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
1 other identifier
interventional
310
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2016
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 30, 2016
CompletedFirst Posted
Study publicly available on registry
April 13, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedMay 17, 2018
May 1, 2018
2.2 years
March 30, 2016
May 12, 2018
Conditions
Outcome Measures
Primary Outcomes (2)
Clinical pregnancy rate
the detection of intrauterine gestational sac with positive pulsations
5 weeks after embryo transfer]
Live birth rate
Pregnancy ending with a live birth
9 months
Secondary Outcomes (8)
Estradiol and Progesterone levels on day of start of progesterone supplementation
12 to 20 days
Endometrial thickness on day of start of progesterone supplementation
12 to 20 days
Number of days needed for adequate (> 8mm) endometrial thickness
12 to 20 days
Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.
12 to 20 days
Chemical pregnancy rate
14 days after embryo transfer
- +3 more secondary outcomes
Study Arms (2)
With GnRHa
ACTIVE COMPARATORCryopreserved-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 COMPARATORCryopreserved-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.
Interventions
The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy
Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation
GnRH agonist given on day 21 of the cycle preceding the embryo transfer
Estradiol started on day1 of the cycle for endometrial prepartaion
progesterone as luteal phase support start after endometrium is well prepared
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
- Nile Ivf Center, Cairo, Egyptcollaborator
- Kamal Shaeer center of infertilitycollaborator
Study Sites (3)
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Cairo, 12411, Egypt
Kamal Shaeer center of infertility
Giza, 12411, Egypt
Nile IVF center
Giza, 12411, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Eman K Shaeer, MD
Cairo University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
March 30, 2016
First Posted
April 13, 2016
Study Start
March 1, 2016
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
May 17, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will share