A Randomized Controlled Study of Prolonging the Time of Progesterone Supplementation to Improve the Pregnancy Outcome of Single Day 6 Blastocyst Transfer of Freeze-thaw Cycle

Phase 2

• Conditions: Infertility
• Interventions: Drug: progesterone

• Registration Number: NCT04938011
• Lead Sponsor: Nanjing University

Brief Summary

This is a single-center, prospective, randomized controlled study. Patients with single blastocyst transfer in the freeze-thaw cycle, aged from 20 to 38 years, with less than three transfers, and with HRT-cycle single D6 blastocyst transfer in the current cycle were enrolled as the study participants. They were randomized into two groups using an Excel table, and the efficacy was evaluated in a blinded manner by a third party who was unaware of the grouping; the data summary phase was performed by blinded statistical analysis with triple separation of the investigator, operator, and statistician.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-06
• Study First Submitted: 2021-06-19
• Study First Submitted QC: 2021-06-19
• Last Update Submitted: 2021-06-19
• Study First Posted: 2021-06-24
• Last Update Posted: 2021-06-24
• Study Start: 2021-07
• Primary Completion: 2023-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 900

Inclusion Criteria

1. Aged 20 to 38 years.
2. Less than three transfers.
3. Undergoing HRT freeze-thaw cycle single blastocyst transfer in the current cycle.
4. Having consented to participate in this study and signed the informed consent form.

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Exclusion Criteria

1. Chromosomal abnormality in either the patient or their partner
2. Contraindications to hormone replacement therapy.
3. Patients with intramural myoma affecting the morphology of the uterine cavity, severe adenomyosis, endometriosis, congenital uterine anomalies, endometrial tuberculosis, intrauterine adhesion and other diseases significantly affecting embryonic implantation.
4. Currently participating in another clinical study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progesterone + 7	progesterone	the transfer of day 6 blastocyst on the 7th day of progesterone supplementation
Progesterone + 6	progesterone	the transfer of day 6 blastocysts on the 6th day of progesterone supplementation

Primary Outcome Measures

Name	Time	Method
Embryo implantation rate	30 days after embryo transplantation

Trial Locations

Locations (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School; 🇨🇳 Nanjing, Jiangsu, China