Freeze-all Policy in Poor Responders
Fresh Versus Frozen Embryos for Infertility in the Poor Responders as Defined by the Bologna Criteria
1 other identifier
interventional
178
1 country
1
Brief Summary
To compare the effects of fresh embryo transfers (ET) and elective frozen-thawed embryo transfer cycles in poor ovarian responders.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 22, 2019
CompletedFirst Posted
Study publicly available on registry
June 26, 2019
CompletedStudy Start
First participant enrolled
July 30, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedJanuary 28, 2020
January 1, 2020
7 months
June 22, 2019
January 25, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Livebirth rate
The proportion of women in the population who had at least one live baby.
32 weeks
Secondary Outcomes (2)
Pregnancy rate
2 weeks
Clinical pregnancy rate
6-8 weeks
Study Arms (2)
Freeze-all
EXPERIMENTALGood 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.
Fresh embryo transfer
NO INTERVENTIONWomen will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).
Interventions
A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Al-Yasmeen Fertility and Gynecology Center
Banhā, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Blinding of the allocated intervention is not possible.
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director
Study Record Dates
First Submitted
June 22, 2019
First Posted
June 26, 2019
Study Start
July 30, 2019
Primary Completion
March 1, 2020
Study Completion
December 30, 2020
Last Updated
January 28, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will share