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Frozen Embryo Transfer in PCOS Patients

Primary Purpose

Infertility

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fertilized embryo Insertion
fertilized embryo Insertion
Sponsored by
Zagazig University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Infertility

Eligibility Criteria

20 Years - 35 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Infertile women fulfilling at least two of the Rotterdam criteria for diagnosis of PCOS; aged 20-35 years; had body mass index (BMI) of less than 35 kg/m2; mild hirsutism on Ferriman-Gallwey (FG) visual scoring system; their hormonal profile of serum AMH >4.5, FSH <5.85 LH>5.39; had no previous attempts of ICSI were included in the study. Exclusion Criteria: Patients who were out of the predetermined age range and BMI; had uterine abnormalities; hydrosaplnix; recurrent miscarriage; medical diseases interfering with or being complicated by occurrence of pregnancy; cases requiring ICSI with TESE samples; had obesity-inducing endocrinopathy severe symptomatizing hypovitaminosis or maintained on hormonal contraception within the last 6 months before inclusion in the study, were excluded from the study.

Sites / Locations

  • Zagazig University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

PCOS Patient

Male factor infertility

Arm Description

Outcomes

Primary Outcome Measures

the live birth rate (LBR) after SBT and DBT

Secondary Outcome Measures

Full Information

First Posted
May 2, 2023
Last Updated
May 2, 2023
Sponsor
Zagazig University
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1. Study Identification

Unique Protocol Identification Number
NCT05854810
Brief Title
Frozen Embryo Transfer in PCOS Patients
Official Title
Single Versus Double Frozen Embryo Transfer in PCOS Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
June 7, 2019 (Actual)
Primary Completion Date
March 5, 2022 (Actual)
Study Completion Date
July 25, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zagazig University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Polycystic ovarian syndrome (PCOS) is condition characterized by being complex, familial and polygenetic metabolic condition with heterogeneous involvement of several genes in the hypothalamic-pituitary-gonadal axis. PCOS is the most incident endocrine-metabolic syndrome that is characterized by hyperandrogenemia, menstrual irregularities, and/or small cysts in one or both ovaries and could be considered as the main cause of female infertility. Assisted reproductive technologies (ART) were defined by the American Center for Disease Control as any fertility-related treatments where eggs or embryos are manipulated. In vitro fertilization involves the transfer of fresh embryos, however, the freeze-all strategy that entails cryopreservation of all embryos to be transferred subsequently in un-stimulated cycle to guard against the negative effects of controlled ovarian stimulation on the endometrium and to minimize the risk of ovarian hyper-stimulation syndrome. Intracytroplasmatic sperm injection (ICSI) is a common procedure used to improve reproductive results, even among couples without male factor infertility. However, there are several points of controversy in the fields of ART traditionally, multiple embryo transfer strategy was used to increase the chance for getting a baby, however, multiple pregnancy is a common complication for this strategy with subsequent adverse fetal, maternal and neonatal outcomes. Also, the developmental stage of embryos at time of transfer; cleavage versus blastocyst was a matter of debit, but giving the chance for in-vitro maturation to the stage of blastocyst increased the possibility of getting good quality embryo to be transferred. However, the exaggeration of prolongation of the in-vitro duration appeared as a trend, but recent studies found no advantages for transfer of D7 or D6 blastocyst over D5 blastocyst transfer (BT).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infertility

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
271 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PCOS Patient
Arm Type
Active Comparator
Arm Title
Male factor infertility
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
fertilized embryo Insertion
Intervention Description
insertion of single fertilized embryo through IVF
Intervention Type
Procedure
Intervention Name(s)
fertilized embryo Insertion
Intervention Description
insertion of double fertilized embryo through IVF
Primary Outcome Measure Information:
Title
the live birth rate (LBR) after SBT and DBT
Time Frame
9 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Infertile women fulfilling at least two of the Rotterdam criteria for diagnosis of PCOS; aged 20-35 years; had body mass index (BMI) of less than 35 kg/m2; mild hirsutism on Ferriman-Gallwey (FG) visual scoring system; their hormonal profile of serum AMH >4.5, FSH <5.85 LH>5.39; had no previous attempts of ICSI were included in the study. Exclusion Criteria: Patients who were out of the predetermined age range and BMI; had uterine abnormalities; hydrosaplnix; recurrent miscarriage; medical diseases interfering with or being complicated by occurrence of pregnancy; cases requiring ICSI with TESE samples; had obesity-inducing endocrinopathy severe symptomatizing hypovitaminosis or maintained on hormonal contraception within the last 6 months before inclusion in the study, were excluded from the study.
Facility Information:
Facility Name
Zagazig University
City
Zagazig
State/Province
Ash Sharqia Governorate
ZIP/Postal Code
44519
Country
Egypt

12. IPD Sharing Statement

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Frozen Embryo Transfer in PCOS Patients

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