Freeze-all Policy in Poor Responders

NCT ID: NCT03999541

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-30

Study Completion Date

2020-12-30

Brief Summary

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

Detailed Description

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Conditions

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Infertility, Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Blinding of the allocated intervention is not possible.

Study Groups

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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.

Group Type EXPERIMENTAL

Freeze-all policy

Intervention Type OTHER

A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer

Fresh embryo transfer

Women will undergo fresh embryo transfer at the cleavage (day 3) or blastocyst stage (day 5).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Freeze-all policy

A policy of freezing all the embryos followed by subsequent thawed frozen embryo transfer

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Al-Yasmeen Fertility and Gynecology Center

OTHER

Sponsor Role lead

Responsible Party

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Yasmin Magdi

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Al-Yasmeen Fertility and Gynecology Center

Banhā, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yasmin Magdi, PhD

Role: CONTACT

00201282313979

Facility Contacts

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Yasmin Magdi, Ph.D

Role: primary

00201282313979

Other Identifiers

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#0014

Identifier Type: -

Identifier Source: org_study_id

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