Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles

May 5, 2015 updated by: Royan Institute

Comparison of Pregnancy Outcomes in Frozen Embryo Transfer in Natural and Hormonal Replacement Cycles: a Randomized Controlled Trial

This study is a prospective randomized controlled trial to compare the pregnancy outcomes of frozen embryo transfer in natural and hormonal replacement cycles. The study population consisted of all infertile women with regular menstrual cycles who will undergo IVF/ICSI and frozen embryo transfer in Reproductive Biomedicine Research Center, Royan institute, Tehran Iran.

Study Overview

Status

Status

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

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.

Detailed Description

In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a) In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.

In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.

In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.

In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.

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 (Anticipated)

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.
460

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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Iran, Islamic Republic of
      • Tehran, Iran, Islamic Republic of
        • Recruiting
        • Royan Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tahere Madani, MD
        • Principal Investigator:
          • Ladan Mohammadi Yegane, MSC
        • Sub-Investigator:
          • Fariba Ramezani, MD
        • Sub-Investigator:
          • Mahnaz Rashidi, BSC
        • Sub-Investigator:
          • Narges Bagheri Lankarani, PhD
        • Sub-Investigator:
          • Fatemeh Hassani, MSC

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 37 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients with regular mensturation cycles
  2. Age 20-37 years
  3. Patients who underwent long protocol
  4. Body mass index (BMI) ≤ 30 kg/m2
  5. Patients who will undergo frozen embryo transfer for the first time

Exclusion Criteria:

  1. Oocyte or embryo donation cycles
  2. Uterine diseases or malformations
  3. Hyper prolactinemia
  4. Thyroid disorders
  5. Tuberculosis
  6. Recurrent abortion history
  7. Severe endometriosis
  8. Ovulation disorders

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.
Experimental: Natural cycle
In natural cycle without hCG, daily monitoring of urinary LH is started from day eight of the cycle and frozen-thawed embryo transfer is planned 3-5 days after detection of LH surge, observing mature follicles in ultrasound and endometrial thickness over 7mm for cleavage embryos.
Biological: frozen Embryo transfer
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
Experimental: Natural cycle + hCG for ovulation induction
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
Biological: frozen Embryo transfer
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
Drug: 10,000U hCG injection
In natural cycle with hCG, after detection of mature follicles in ultrasound and endometrial thickness over 7mm, 10,000IU hCG is injected for ovulation and embryo transfer is performed 3-5 days later in cleavage stage.
Experimental: Hormonally controlled cycle with GnRH-a
In this group , injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
Biological: frozen Embryo transfer
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
Drug: GnRH agonist (Superfact)
In group 3, injection of GnRH agonist (Superfact) at a subcutaneous daily dose of 0.5 mg is started on the day 17-19 of the natural menstrual cycle. Once pituitary desensitization is confirmed, hormonal treatment is commenced with 4mg/day oral Estradiol valerate and after 7 days if endometrial thickness is adequate, Estradiol administration will be continued with the same dose and 100mg Progesterone is administered before embryo transfer, otherwise patients are candidates for higher dosage of Estradiol till favourable endometrial thickness is achieved.
Experimental: Hormonally controlled cycle without GnRH-a
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.
Biological: frozen Embryo transfer
In this study all patients who will undergo frozen embryo transfer are randomly allocated to be prepared for transfer by using either natural cycle (with or without hCG for ovulation induction) or Hormonal cycle (with or without administration of GnRH-a).
Drug: administration of 6 mg Estradiol valerate
In the hormonal group without GnRH-a, endometrial preparation will be started with daily administration of 6 mg Estradiol valerate from the 2nd day of the natural menstrual cycle for 6 days. Then treatment will be continued similar to the 3rd group.

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: 4 weeks
The pregnancy rate will be evaluated in patients of each groups 4-6 weeks after embryo transfer.
4 weeks

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
Implantation rate
Time Frame: 4 weeks
Evaluation the implantation rate in patients of each groups 4-6 weeks after frozen embryo transfer
4 weeks
chemical pregnancy rates
Time Frame: 2 weeks
Evaluation the chemical pregnancy rates in patients of each group 2 weeks after embryo transfer.
2 weeks
Ongoing pregnancy
Time Frame: 12 weeks
Evaluation the ongoing pregnancy in patients of each group 12 weeks after embryo transfer.
12 weeks
miscarriage rate
Time Frame: 12 weeks
Evaluation the miscarriage rate in patients of each group 12 weeks after embryo transfer.
12 weeks

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.
Royan Institute

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: Tahereh Madani, MD, Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran
  • Principal Investigator: Ladan Mohammadi Yeganeh, MSC, Department of Endocrinology and Female Infertility at Reproductive Biomedicine Research Center, Royan Institute for Reproductive Biomedicine, ACECR, Tehran, Iran

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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

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.
September 1, 2012

Primary Completion (Anticipated)

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.
October 1, 2015

Study Completion (Anticipated)

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.
November 1, 2015

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).
September 23, 2014

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.
September 25, 2014

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.
September 29, 2014

Study Record Updates

Last Update Posted (Estimate)

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 6, 2015

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 5, 2015

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.
April 1, 2012

More Information

Terms related to this study

Keywords

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.
  • Royan-Emb-019

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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