Administration of Human Chorionic Gonadotrophin Before Secretory Transformation of Frozen-thawed Embryo Transfer Cycles

Phase 4

Completed

• Conditions: FET; Frozen-thawed Embryo Transfe; hCG; Human Chorionic Gonadotrophin
• Interventions: Drug: Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU

• Registration Number: NCT05340010
• Lead Sponsor: Alexandria University

Brief Summary

Successful embryo implantation is complicated process that requires synchrony between good-quality embryos and receptive endometrium. Human chorionic gonadotropin (hCG), is one of the initial embryonic signals and the major embryoendometrial relationship regulator. This study will be conducted to to investigate the role of parenteral hCG used for the transfer of cryopreserved- thawed embryos with HRT cycles in the outcome of artificially prepared frozen embryo transfer (FET) cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-01
• Status Verified: 2021-12
• Study First Submitted: 2022-02-08
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-21
• Primary Completion: 2022-06-20
• Study Completion: 2022-07-30
• Last Update Submitted: 2022-08-27
• Last Update Posted: 2022-09-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

• Patient age ≤ 38 years.
• Normal 3D transvaginal ultrasound.
• At least two good quality embryos cryopreserved by vitrification.
• No GnRH agonists administration before FET cycle.

Exclusion Criteria

• Endometriosis.
• Uterine anomalies.
• Evidence of hydrosalpinx by hystrosalpingography or ultrasound.
• Evidence of immune disease, hematological or hormonal disorder.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
HCG group	Human Chorionic Gonadotrophin Intramuscular injection 10.000 IU	n Group 1 (hCG): participants will receive endometrial preparation with estrogen and an intramuscular hCG injection will before progesterone supplementation

Primary Outcome Measures

Name	Time	Method
Live birth delivery rate (LBR)	7 months	Number of live births beyond 28 weeks of gestational age to the total number of FET cycles

Secondary Outcome Measures

Name	Time	Method
Clinical pregnancy rate	2 weeks after positive pregnancy test	number of cases with observed gestational sac with embryonic heartbeat detected by ultrasound two weeks after positive pregnancy to the totoal number of frozen embryo transfer cycles.
Implantation rate	2 weeks after positive pregnancy test	proportion of the number of gestational sacs to the number of embryos transferred
Miscarriage rate	20 weeks gestational age	number of lost before the 20th week of gestation to the number of clinical pregnancies

Trial Locations

Locations (1)

Alexandria university; 🇪🇬 Alexandria, Egypt