Frozen Embryo Transfer in PCOS Patients

Single Versus Double Frozen Embryo Transfer in PCOS Patients

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).

Study Overview

• Status: Completed
• Conditions: Infertility
• Intervention / Treatment: Procedure: fertilized embryo Insertion; Procedure: fertilized embryo Insertion

• Study Type: Interventional
• Enrollment (Actual): 271
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Ash Sharqia Governorate
    • Zagazig, Ash Sharqia Governorate, Egypt, 44519
      • Zagazig University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: PCOS Patient	Procedure: fertilized embryo Insertion; insertion of single fertilized embryo through IVF; Procedure: fertilized embryo Insertion; insertion of double fertilized embryo through IVF
Active Comparator: Male factor infertility	Procedure: fertilized embryo Insertion; insertion of single fertilized embryo through IVF; Procedure: fertilized embryo Insertion; insertion of double fertilized embryo through IVF

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
the live birth rate (LBR) after SBT and DBT	9 months

Collaborators and Investigators

• Sponsor: Zagazig University

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2019
• Primary Completion (Actual): March 5, 2022
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: May 2, 2023
• First Submitted That Met QC Criteria: May 2, 2023
• First Posted (Estimate): May 11, 2023

Study Record Updates

• Last Update Posted (Estimate): May 11, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infertility
• Other Study ID Numbers: ZU-IRB 10066/27-11-2022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No