Frozen Embryo Transfer in PCOS Patients

Infertility Clinical Trial

Official title:

Single Versus Double Frozen Embryo Transfer in PCOS Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05854810
• Other study ID #: ZU-IRB 10066/27-11-2022
• Status: Completed
• Phase: N/A
• Start date: June 7, 2019
• Est. completion date: July 25, 2022

Study information

• Verified date: May 2023
• Source: Zagazig University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 271
• Est. completion date: July 25, 2022
• Est. primary completion date: March 5, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Procedure:
• fertilized embryo Insertion
insertion of single fertilized embryo through IVF
• fertilized embryo Insertion
insertion of double fertilized embryo through IVF

Locations

Country	Name	City	State
Egypt	Zagazig University	Zagazig	Ash Sharqia Governorate

Sponsors (1)

Lead Sponsor	Collaborator
Zagazig University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the live birth rate (LBR) after SBT and DBT		9 months