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

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ClinicalTrials.gov Identifier: NCT02736032
Recruitment Status : Completed
First Posted : April 13, 2016
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
Nile Ivf Center, Cairo, Egypt
Kamal Shaeer center of infertility
Information provided by (Responsible Party):
Yasmin Ahmed Bassiouny, Cairo University

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
Infertility Procedure: Embryo transfer Procedure: Serum Estradiol and Progesterone levels Drug: GnRH agonist Drug: External Estradiol Drug: Progesterone Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : March 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility
Drug Information available for: Estradiol

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 Name: Decapeptyl SR

Drug: External Estradiol
Estradiol started on day1 of the cycle for endometrial prepartaion
Other Name: estradiol valerate of Cycloprogenova tablets

Drug: Progesterone
progesterone as luteal phase support start after endometrium is well prepared
Other Name: 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 Name: estradiol valerate of Cycloprogenova tablets

Drug: Progesterone
progesterone as luteal phase support start after endometrium is well prepared
Other Name: Cyclogest vaginal suppositories




Primary Outcome Measures :
  1. Clinical pregnancy rate [ Time Frame: 5 weeks after embryo transfer] ]
    the detection of intrauterine gestational sac with positive pulsations

  2. Live birth rate [ Time Frame: 9 months ]
    Pregnancy ending with a live birth


Secondary Outcome Measures :
  1. Estradiol and Progesterone levels on day of start of progesterone supplementation [ Time Frame: 12 to 20 days ]
    The serum levels of estradiol and progesterone before embryo transfer

  2. Endometrial thickness on day of start of progesterone supplementation [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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 [ Time Frame: 14 days after embryo transfer ]
    positive serum Beta HCG 14 days after embryo transfer

  6. Implantation rate. [ Time Frame: 5 weeks after embryo transfer ]
    the ratio between the number of embryos transferred and the number of sacs

  7. Early miscarriage rate [ Time Frame: 3 months ]
    Pregnancy loss in the first 12 weeks gestation

  8. Ongoing pregnancy rate [ Time Frame: 3 months ]
    Pregnancy ongoing beyond 12 weeks gestation



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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736032


Locations
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Egypt
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
Cairo, Egypt, 12411
Kamal Shaeer center of infertility
Giza, Egypt, 12411
Nile IVF center
Giza, Egypt, 12411
Sponsors and Collaborators
Cairo University
Nile Ivf Center, Cairo, Egypt
Kamal Shaeer center of infertility
Investigators
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Study Director: Eman K Shaeer, MD Cairo University

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Responsible Party: Yasmin Ahmed Bassiouny, Dr, Cairo University
ClinicalTrials.gov Identifier: NCT02736032     History of Changes
Other Study ID Numbers: 12016
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Infertility
Genital Diseases, Male
Genital Diseases, Female
Estradiol 3-benzoate
Estradiol 17 beta-cypionate
Estradiol
Polyestradiol phosphate
Progesterone
Deslorelin
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Contraceptive Agents
Reproductive Control Agents
Contraceptive Agents, Female
Progestins
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action