Freeze-all Policy in Poor Responders

January 25, 2020 updated by: Yasmin Magdi, Al-Yasmeen Fertility and Gynecology Center

Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria

To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

178

Phase

  • Not Applicable

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 Locations

      • Banhā, Egypt
        • Recruiting
        • Al-Yasmeen fertility and gynecology center
        • Contact:

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

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients that fulfill the Bologna criteria [at least 2 of the following 3 features must be present: (i) advanced maternal age or any other risk factor for POR; (ii) a previous POR; and (iii) an abnormal ovarian reserve test (ORT)]
  • if the progesterone serum level was ≤1.5 ng/mL on the trigger day.
  • body mass index 18-32 kg/m2
  • Both partners are able to provide written informed consent.
  • At least 1 good quality embryo on day 3 after egg collection on day 3 according to the Istanbul consensus (7-8 cells; with symmetric blastomeres and <10% fragmentation by volume).
  • Endometrial thickness ≥8 mm on trigger day.
  • a normal uterine cavity on ultrasound.
  • IVF/ICSI with only fresh semen

Exclusion Criteria:

  • Pre-implantation genetic testing is being planned.
  • if they had severe endometriosis, uterine pathology (myomas, adenomyosis, endocrinopathies, adhesions, acquired or congenital abnormalities), untreated tubal hydrosalpinges, ovarian tumor, recurrent spontaneous abortion, implantation failure after ≥ 2 fresh or frozen ET.

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Freeze-all
Good quality embryos (either day 3 or 5) will be frozen and subsequent frozen embryo transfer will be arranged within three months of the egg retrival.
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
No Intervention: Fresh embryo transfer
Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Livebirth rate
Time Frame: 32 weeks
The proportion of women in the population who had at least one live baby.
32 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pregnancy rate
Time Frame: 2 weeks
Positive pregnancy test at two weeks +/- three days after embryo transfer
2 weeks
Clinical pregnancy rate
Time Frame: 6-8 weeks
The presence of at least one fetal heartbeat at ultrasound between six and eight weeks of gestation
6-8 weeks

Collaborators and Investigators

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

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)

July 30, 2019

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

December 30, 2020

Study Registration Dates

First Submitted

June 22, 2019

First Submitted That Met QC Criteria

June 25, 2019

First Posted (Actual)

June 26, 2019

Study Record Updates

Last Update Posted (Actual)

January 28, 2020

Last Update Submitted That Met QC Criteria

January 25, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • #0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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