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

Primary Purpose

Infertility

Status
Completed
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Embryo transfer
Serum Estradiol and Progesterone levels
GnRH agonist
External Estradiol
Progesterone
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
  • Kamal Shaeer center of infertility
  • Nile IVF center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

With GnRHa

Without GnRHa

Arm 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.

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.

Outcomes

Primary Outcome Measures

Clinical pregnancy rate
the detection of intrauterine gestational sac with positive pulsations
Live birth rate
Pregnancy ending with a live birth

Secondary Outcome Measures

Estradiol and Progesterone levels on day of start of progesterone supplementation
The serum levels of estradiol and progesterone before embryo transfer
Endometrial thickness on day of start of progesterone supplementation
The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos
Number of days needed for adequate (> 8mm) endometrial thickness
Number of days on external hormones to prepare endometrium
Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.
Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.
Chemical pregnancy rate
positive serum Beta HCG 14 days after embryo transfer
Implantation rate.
the ratio between the number of embryos transferred and the number of sacs
Early miscarriage rate
Pregnancy loss in the first 12 weeks gestation
Ongoing pregnancy rate
Pregnancy ongoing beyond 12 weeks gestation

Full Information

First Posted
March 30, 2016
Last Updated
May 12, 2018
Sponsor
Cairo University
Collaborators
Nile Ivf Center, Cairo, Egypt, Kamal Shaeer center of infertility
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1. Study Identification

Unique Protocol Identification Number
NCT02736032
Brief Title
Cryopreserved-thawed Embryo Transfer With or Without Gonadotropin Releasing Hormone Agonist
Official Title
Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2016 (Actual)
Primary Completion Date
May 2018 (Actual)
Study Completion Date
May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
Collaborators
Nile Ivf Center, Cairo, Egypt, Kamal Shaeer center of infertility

4. Oversight

Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
310 (Actual)

8. Arms, Groups, and Interventions

Arm Title
With GnRHa
Arm Type
Active Comparator
Arm 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.
Arm Title
Without GnRHa
Arm Type
Active Comparator
Arm 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.
Intervention Type
Procedure
Intervention Name(s)
Embryo transfer
Intervention Description
The transfer of cryopreserved-thawed embryos inside the uterus aiming to achieve pregnancy
Intervention Type
Procedure
Intervention Name(s)
Serum Estradiol and Progesterone levels
Intervention Description
Serum estradiol and serum progesterone levels in blood on the day of start of progesterone supplementation
Intervention Type
Drug
Intervention Name(s)
GnRH agonist
Other Intervention Name(s)
Decapeptyl SR
Intervention Description
GnRH agonist given on day 21 of the cycle preceding the embryo transfer
Intervention Type
Drug
Intervention Name(s)
External Estradiol
Other Intervention Name(s)
estradiol valerate of Cycloprogenova tablets
Intervention Description
Estradiol started on day1 of the cycle for endometrial prepartaion
Intervention Type
Drug
Intervention Name(s)
Progesterone
Other Intervention Name(s)
Cyclogest vaginal suppositories
Intervention Description
progesterone as luteal phase support start after endometrium is well prepared
Primary Outcome Measure Information:
Title
Clinical pregnancy rate
Description
the detection of intrauterine gestational sac with positive pulsations
Time Frame
5 weeks after embryo transfer]
Title
Live birth rate
Description
Pregnancy ending with a live birth
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Estradiol and Progesterone levels on day of start of progesterone supplementation
Description
The serum levels of estradiol and progesterone before embryo transfer
Time Frame
12 to 20 days
Title
Endometrial thickness on day of start of progesterone supplementation
Description
The endometrial thickness on the day of starting progesterone supplementation to transfer the embryos
Time Frame
12 to 20 days
Title
Number of days needed for adequate (> 8mm) endometrial thickness
Description
Number of days on external hormones to prepare endometrium
Time Frame
12 to 20 days
Title
Cycle cancellation: not related to thawing, thin endometrium, high P. OR related to embryos not surviving thawing.
Description
Cycle cancellation: not related to thawing, thin endometrium, high Progesterone. OR related to embryos not surviving thawing.
Time Frame
12 to 20 days
Title
Chemical pregnancy rate
Description
positive serum Beta HCG 14 days after embryo transfer
Time Frame
14 days after embryo transfer
Title
Implantation rate.
Description
the ratio between the number of embryos transferred and the number of sacs
Time Frame
5 weeks after embryo transfer
Title
Early miscarriage rate
Description
Pregnancy loss in the first 12 weeks gestation
Time Frame
3 months
Title
Ongoing pregnancy rate
Description
Pregnancy ongoing beyond 12 weeks gestation
Time Frame
3 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eman K Shaeer, MD
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
City
Cairo
ZIP/Postal Code
12411
Country
Egypt
Facility Name
Kamal Shaeer center of infertility
City
Giza
ZIP/Postal Code
12411
Country
Egypt
Facility Name
Nile IVF center
City
Giza
ZIP/Postal Code
12411
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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