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

Sponsor
Cairo University (Other)
Overall Status
Completed
CT.gov ID
NCT02736032
Collaborator
Nile Ivf Center, Cairo, Egypt (Other), Kamal Shaeer center of infertility (Other)
310
Enrollment
3
Locations
2
Arms
26
Actual Duration (Months)
103.3
Patients Per Site
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Embryo transfer
  • Procedure: Serum Estradiol and Progesterone levels
  • Drug: GnRH agonist
  • Drug: External Estradiol
  • Drug: Progesterone
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
310 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study
Actual Study Start Date :
Mar 1, 2016
Actual Primary Completion Date :
May 1, 2018
Actual Study Completion Date :
May 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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.

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

    		•
    Active Comparator: 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.

    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: 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical pregnancy rate [5 weeks after embryo transfer]]

      the detection of intrauterine gestational sac with positive pulsations

    2. Live birth rate [9 months]

      Pregnancy ending with a live birth

    Secondary Outcome Measures

    1. 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

    2. 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

    3. Number of days needed for adequate (> 8mm) endometrial thickness [12 to 20 days]

      Number of days on external hormones to prepare endometrium

    4. 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.

    5. Chemical pregnancy rate [14 days after embryo transfer]

      positive serum Beta HCG 14 days after embryo transfer

    6. Implantation rate. [5 weeks after embryo transfer]

      the ratio between the number of embryos transferred and the number of sacs

    7. Early miscarriage rate [3 months]

      Pregnancy loss in the first 12 weeks gestation

    8. Ongoing pregnancy rate [3 months]

      Pregnancy ongoing beyond 12 weeks gestation

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 35 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini) Cairo Egypt 12411
    2 Kamal Shaeer center of infertility Giza Egypt 12411
    3 Nile IVF center Giza Egypt 12411

    Sponsors and Collaborators

    • Cairo University
    • Nile Ivf Center, Cairo, Egypt
    • Kamal Shaeer center of infertility

    Investigators

    • Study Director: Eman K Shaeer, MD, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yasmin Ahmed Bassiouny, Dr, Cairo University
    ClinicalTrials.gov Identifier:
    NCT02736032
    Other Study ID Numbers:
    • 12016
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    May 17, 2018
    Last Verified:
    May 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Additional relevant MeSH terms:
    Infertility
    Triptorelin Pamoate
    Estradiol 17 beta-cypionate
    Estradiol 3-benzoate
    Estradiol
    Polyestradiol phosphate
    Progesterone

    Study Results

    No Results Posted as of May 17, 2018