Effect of Low Molecular Weight Heparin in Freeze-thaw Embryo Transfer Cycles in Women With Recurrent Implantation Failure

Completed

• Conditions: Low Molecular Weight Heparin; Recurrent Implantation Failure; FET; IVF
• Interventions: Drug: Low Molecular Weight Heparine

• Registration Number: NCT06991530
• Lead Sponsor: The Second Hospital of Shandong University

Brief Summary

Recurrent implantation failure (RIF) is considered a tough problem in assisted reproductive technology (ART) without effective treatments. The effect of low molecular weight heparin (LMWH) in pregnancy outcomes is controversial. In addition, there are few reports on the role of LMWH in population with RIF performing freeze-thaw embryo transfer (FET) cycles. The purpose of this study is to evaluate the effect of LMWH on pregnancy outcomes in women with FET cycles.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-01
• Primary Completion: 2024-11-30
• Study Completion: 2025-03-01
• Study First Submitted: 2025-04-29
• Status Verified: 2025-05
• Study First Submitted QC: 2025-05-18
• Last Update Submitted: 2025-05-18
• Study First Posted: 2025-05-28
• Last Update Posted: 2025-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 392

Inclusion Criteria

• Women under or equal to the age of 40 when oocytes were retrieved;
• The history of at least 2 failed fresh embryo transfer/FET cycles and cumulative transfer of ≥ 3 high-quality embryos or cumulative transfer of ≥ 2 blastocysts;
• Planning to FET after IVF or ICSI cycles

Exclusion Criteria

• Women with untreated hydrosalpinx, uterine cavity occupying lesions (uterine adhesions, submucous fibroids, endometrial polyps, et al.);
• Women with abnormal anatomical structure of uterus (unicornuate uterus, bipedal uterus, et al.);
• Women with endometrial thickness (EMT) < 6mm on the day of transplantation;
• Women or their partner with abnormal chromosome karyotype (not including chromosome polymorphisms);
• Women with the history of recurrent spontaneous abortion (RSA);
• Women with a history of autoimmune or coagulation disorders;
• Women with contraindications to LMWH

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
LMWH group	Low Molecular Weight Heparine	the LMWH group received injections of 4100 IU/d LMWH from the day of transplant

Primary Outcome Measures

Name	Time	Method
Ongoing pregnancy rate	from transplantation to delivery (assessed up to 40 weeks of gestation)	The number of ongoing pregnancies divided by the number of women who received a transfer

Secondary Outcome Measures

Name	Time	Method
Miscarriage rate	from transplantation to delivery (assessed up to 40 weeks of gestation)	The number of miscarriages divided by the number of clinical pregnancies
biochemical pregnancy rate	from transplantation to delivery (assessed up to 40 weeks of gestation)	The number of biochemical pregnancy cycles divided by the number of transplantation cycles
clinical pregnancy rate	from transplantation to delivery (assessed up to 40 weeks of gestation)	The number of clinical pregnancies divided by the number of women who received a transfer
ectopic pregnancy rate	from transplantation to delivery (assessed up to 40 weeks of gestation)	The number of ectopic pregnancies divided by the number of women who received a transfer

Trial Locations

Locations (1)

The Second Hospital of Shandong University; 🇨🇳 Jinan, Shandong, China