Comparative Study Between Fresh and Frozen Embryo Transfer in PCOS Patients Undergoing IVF Treatment

NCT ID: NCT05167838

Last Updated: 2022-04-12

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

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-01

Study Completion Date

2022-07-01

Brief Summary

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The objective of our study is to compare in vitro fertilization (IVF) outcomes between fresh embryo transfer (ET) and frozen-thawed ET in women with polycystic ovary syndrome (PCOS).

Detailed Description

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Eligible women will be randomized to two groups in a ratio of 1:1 . Both the patients and the clinicians will be aware of the allocated arm. The patients (110) will be equally randomized into two groups:

Group A will undergo a day 3 fresh embryo transfer after ovarian stimulation, luteal phase support will be started just after follicular aspiration. Group B will have all of their embryo cryopreserved after ovarian stimulation with no luteal phase support after the aspiration and then undergo a frozen-thawed day 3 embryo transfer.

Controlled ovarian stimulation will be done using the gonadotropin releasing hormone (GnRH) antagonist protocol then human chorionic gonadotropin( HCG) 5000 IU trigger for final oocyte maturation.

Conditions

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IVF

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Group 1; Fresh embryo transfer in PCO patients Group 2: Frozen ET in PCO patients
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

Fresh embryo transfer group

Group Type EXPERIMENTAL

fresh embryo transfer

Intervention Type PROCEDURE

55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support

Group B

Frozen embryo transfer group

Group Type EXPERIMENTAL

Frozen embryo transfer

Intervention Type PROCEDURE

55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.

Interventions

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fresh embryo transfer

55 patients undergoing fresh embryo transfer after ovarian stimulation followed by luteal phase support

Intervention Type PROCEDURE

Frozen embryo transfer

55 patients undergoing frozen embryo transfer after ovarian stimulation followed by cryopreservation of all embryos and transfer in another cycle.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Women diagnosed with PCOS according to modified Rotterdam criteria which includes menstrual abnormalities combined with either hyperandrogenism (hirsutism diagnosed by modified Ferriman-Gallwey score or elevated total testosterone level) or polycystic ovaries.
* Women ages ≥20 and \<40years old.
* BMI less than 35.
* Women who have a history of infertility.
* All patients will receive adjuvant drugs for ovulation induction (metformin from preceding cycle, cabergoline 1 tab daily for 8 days and 500 cc colloid solution on day of ovum pick up).

Exclusion Criteria

* History of unilateral oophorectomy.
* Uterine abnormalities such as a malformed uterus (unicornuate, septate uterus), adenomyosis, submucous myoma or intrauterine adhesion.
* Severe male factor for infertility such as azoospermia.
* History of repeated ICSI trials failure.
* Women who are unable to comply with the study procedures.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Marwa Mohamed Mahmoud Eid

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marwa Mo Eid, MD

Role: PRINCIPAL_INVESTIGATOR

Cairo U

Locations

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Marwa Eid

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Marwa Mo Eid, Ass.prof

Role: CONTACT

01001225079

Abdullah S ha, Ass.Lecturer

Role: CONTACT

01001409468

Facility Contacts

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Marwa M Eid, MD

Role: primary

01001225079

Abdullah S Ha, Ass.lecturer

Role: backup

01001409468

Other Identifiers

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Cairo University obgyn

Identifier Type: -

Identifier Source: org_study_id

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