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

NCT ID: NCT04938011

Last Updated: 2021-06-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-31

Study Completion Date

2024-06-30

Brief Summary

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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

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Conditions

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Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Progesterone + 7

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

Group Type EXPERIMENTAL

progesterone

Intervention Type DRUG

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

Progesterone + 6

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

Group Type ACTIVE_COMPARATOR

progesterone

Intervention Type DRUG

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

Interventions

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progesterone

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

Intervention Type DRUG

progesterone

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

38 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Nanjing University

OTHER

Sponsor Role lead

Responsible Party

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Li-jun Ding

Reproductive Medicine Center of The Affiliated Drum Tower Hospital of Nanjing University Medical School

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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

Nanjing, Jiangsu, China

Site Status

Countries

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China

Central Contacts

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Yue Jiang, PhD

Role: CONTACT

025-83106666

References

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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.

Reference Type DERIVED
PMID: 36536470 (View on PubMed)

Other Identifiers

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SZ-2021-0616

Identifier Type: -

Identifier Source: org_study_id

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