- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03999541
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
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
- Name: Yasmin Magdi, PhD
- Phone Number: 00201282313979
- Email: Yas.magdi@hotmail.com
Study Locations
-
-
-
Banhā, Egypt
- Recruiting
- Al-Yasmeen fertility and gynecology center
-
Contact:
- Yasmin Magdi, Ph.D
- Phone Number: 00201282313979
- Email: Yas.magdi@hotmail.com
-
-
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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