What is the Optimal Cycle Regimen for Frozen- Thawed Embryo Transfer Cycles

Terminated

• Conditions: Infertility; Pregnancy Early; Female Infertility

• Registration Number: NCT03954587
• Lead Sponsor: ART Fertility Clinics LLC

Brief Summary

Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

Detailed Description

The most common treatment protocols for frozen embryo transfers include natural cycles with or without human chorionic gonadotrophin (HCG) trigger or endometrial preparation with hormonal treatment (artificial cycles), with or without Gonadotrophin - releasing hormone agonist suppression. Recent studies comparing artificial and natural cycles concluded that the optimal means of endometrial preparation for frozen- thawed cycle remains unclear and both options may be offered to women with regular ovulatory cycles.

Correctly identified spontaneous natural cycles are the preferred option for frozen-thawed embryo transfer in women with regular menstrual cycles.

Investigators will be comparing artificial (HRT) frozen-thawed embryo transfer cycles to correctly conducted spontaneous natural cycles after the transfer of a chromosomally normal embryo.

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-16
• Study First Posted: 2019-05-17
• Study Start: 2019-06-10
• Primary Completion: 2020-07-15
• Study Completion: 2020-07-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-04
• Last Update Posted: 2021-03-08

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 4

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate to 8 weeks gestation	8 weeks	viable pregnancy to 8 gestational weeks
Biochemical pregnancy rate	5 weeks	Positive ß-hCG, but at 5 gestational weeks no ultrasonographic visible gestational sac seen
Clinical implantation rate	6 weeks	Number of gestational sacs observed by ultrasound at 6 weeks of gestation divided by the number of embryos transferred
Clinical pregnancy rate	5 weeks	Ultrasonographic visible sac at 5 gestational weeks
Pregnancy rate beta human chorionic gonadotropin (ß-hCG) > 5 IU	12 days	Number of patients with a hCG \> 5 IU out of the number of patients who underwent an embryo transfer with one or two euploid embryos

Trial Locations

Locations (1)

IVI Middle East Fertility Clinic; 🇦🇪 Abu Dhabi, United Arab Emirates