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

May 12, 2018 updated by: Yasmin Ahmed Bassiouny, Cairo University

Cryopreserved-thawed Embryo Transfer in Down or Non-down Regulated Hormonally Controlled Cycles: a Prospective, Randomized Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
310

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 12411
        • IVF centre, Obstetrics and Gynaecology Department, Cairo University Hospitals (Kasr EL Aini)
      • Giza, Egypt, 12411
        • Nile IVF center
      • Giza, Egypt, 12411
        • Kamal Shaeer center of infertility

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Clinical pregnancy rate
Time Frame: 5 weeks after embryo transfer]
the detection of intrauterine gestational sac with positive pulsations
5 weeks after embryo transfer]
Live birth rate
Time Frame: 9 months
Pregnancy ending with a live birth
9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
12 to 20 days
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
12 to 20 days
Number of days needed for adequate (> 8mm) endometrial thickness
Time Frame: 12 to 20 days
Number of days on external hormones to prepare endometrium
12 to 20 days
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.
12 to 20 days
Chemical pregnancy rate
Time Frame: 14 days after embryo transfer
positive serum Beta HCG 14 days after embryo transfer
14 days after embryo transfer
Implantation rate.
Time Frame: 5 weeks after embryo transfer
the ratio between the number of embryos transferred and the number of sacs
5 weeks after embryo transfer
Early miscarriage rate
Time Frame: 3 months
Pregnancy loss in the first 12 weeks gestation
3 months
Ongoing pregnancy rate
Time Frame: 3 months
Pregnancy ongoing beyond 12 weeks gestation
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nile Ivf Center, Cairo, Egypt
Kamal Shaeer center of infertility

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Eman K Shaeer, MD, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 12, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 17, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 12016

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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