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

NCT04938011 | Unknown Phase 2 DMC

• 1 other identifier: SZ-2021-0616
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

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.

Conditions

Infertility

Outcome Measures

Primary Outcomes (1)

• Embryo implantation rate

  30 days after embryo transplantation

Study Arms (2)

Progesterone + 7

EXPERIMENTAL

the transfer of day 6 blastocyst on the 7th day of progesterone supplementation

Drug: progesterone

Progesterone + 6

ACTIVE COMPARATOR

the transfer of day 6 blastocysts on the 6th day of progesterone supplementation

Drug: progesterone

Interventions

progesterone DRUG

the transfer of day 6 blastocyst on the 6th day of progesterone supplementation

Progesterone + 6

Eligibility Criteria

• Age: 20 Years - 38 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Chromosomal abnormality in either the patient or their partner
• Contraindications to hormone replacement therapy.
• 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.
• Currently participating in another clinical study.

Sponsors & Collaborators

• Nanjing University: lead

Study Sites (1)

Reproductive Medicine Center, The affiliated Drum Towel Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

Location

Related Publications (1)

• Xu M, Yan Y, Shen X, Sun H, Yan G, Kong N, Jiang Y. Prolonging the time of progesterone supplementation to improve the pregnancy outcomes of single day 6 blastocyst transfer in frozen-thawed cycles: study protocol for a randomized controlled trial. Trials. 2022 Dec 19;23(1):1024. doi: 10.1186/s13063-022-07013-1.

  PMID: 36536470 DERIVED

MeSH Terms

Conditions

Infertility

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Genital Diseases; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Central Study Contacts

Yue Jiang, PhD

CONTACT

025-83106666; jiangyue85@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical School

Study Record Dates

• First Submitted: June 19, 2021
• First Posted: June 24, 2021
• Study Start: July 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 24, 2021

Record last verified: 2021-06

Locations

CN (1)