NCT06005207

Brief Summary

This study is a single-center, randomized, controlled prospective study. Those patients with repeated implantation failure (RIF) who will recieve frozen thawed embryo transfer (FET) are enrolled in the study. To determine the effect of vaginal progesterone on the clinical pregnancy outcomes of RIF patients.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
152

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 15, 2023

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

August 22, 2023

Status Verified

August 1, 2023

Enrollment Period

1.4 years

First QC Date

August 15, 2023

Last Update Submit

August 15, 2023

Conditions

Infertility, Female

Outcome Measures

Primary Outcomes (1)

  • Embryo implantation rate

    The proportion of the number of implanted embryos to the total number of transferred embryos is the embryo implantation rate.

    45 days after embryo transfer

Secondary Outcomes (4)

  • Clinical pregnancy rate

    45 days after embryo transfer

  • Early pregnancy loss rate

    12 weeks after embryo transfer

  • Persistent pregnancy rate

    20 weeks after embryo transfer

  • Live birth rate

    40 weeks after embryo transfer

Study Arms (2)

Vaginal progesterone supplementation

EXPERIMENTAL

90 mg progesterone vaginal sustained-release gel is added daily to induce endometrial transformation and luteal support

Drug: progesterone vaginal sustained-release gel

Regular progesterone

NO INTERVENTION

No additional vaginal progesterone gel, routine endometrial transformation and luteal support drugs

Interventions

progesterone vaginal sustained-release gelDRUG

90 mg progesterone vaginal sustained-release gel is added daily during endometrial transformation and luteal support

Vaginal progesterone supplementation

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Aged between 20 and 40 years old;
  • BMI: 18-28 kg/m2；
  • Consistent with the diagnosis of repeated implantation failure of unknown reasons, the previous embryo transfer situation meets one of the following:
  • Total embryos transferred ≥ 4 high-quality cleavage-stage embryos; ≥ 2 blastocysts; ≥ 2 high quality cleavage-stage embryos +≥ 1 blastocysts;
  • At least 1 high-quality embryo remained for embryo transfer;
  • Volunteer to participate in the study and sign the informed consent form.

You may not qualify if:

  • Patients with recurrent pregnancy loss (≥ 2 biochemical pregnancies or ≥ 2 spontaneous abortions);
  • Adverse pregnancy history (stillbirth, fetal malformation, etc.);
  • Severe paternal factors: need for TESA or PESA;
  • PGT;
  • Failure of embryo implantation due to any definite reason, including but not limited to: endometrial adhesion (moderate to severe), thin endometrium (\<7 mm before transformation), endometritis, endometriosis (medium or severe), adenomyosis, untreated hydrosalpinx, hysteromyoma (submucosal fibroids, non submucosal fibroids \> 4.0 cm and/or endometrial compression), reproductive malformation, serious immune disease, serious coagulation function abnormality;
  • Chromosome abnormality of either spouse;
  • Those with contraindications to pregnancy or assisted reproductive technology.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Nanjing, Jiangsu, 210008, China

RECRUITING

MeSH Terms

Conditions

Infertility, Female

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesInfertility

Central Study Contacts

Chenyang Huang

CONTACT

+862583107188dianshui19901562@126.com

Na Kong

CONTACT

+862583107188xtalkn@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

August 15, 2023

First Posted

August 22, 2023

Study Start

August 1, 2023

Primary Completion

December 31, 2024

Study Completion

December 31, 2025

Last Updated

August 22, 2023

Record last verified: 2023-08

Locations

CN(1)