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

Infertility Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04938011
• Other study ID #: SZ-2021-0616
• Status: Not yet recruiting
• Phase: Phase 2
• Start date: July 2021
• Est. completion date: June 2024

Study information

• Verified date: June 2021
• Source: Nanjing University
• Contact: Yue Jiang, PhD
• Phone: 025-83106666
• Email: jiangyue85[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 900
• Est. completion date: June 2024
• Est. primary completion date: June 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 38 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Infertility

Intervention

Drug:
• progesterone
the transfer of day 6 blastocyst on the 6th day of progesterone supplementation
• progesterone
the transfer of day 6 blastocyst on the 7th day of progesterone supplementation

Locations

Country	Name	City	State
China	Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Embryo implantation rate		30 days after embryo transplantation