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

NCT ID: NCT06991530

Last Updated: 2025-08-12

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 392 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2025-03-01

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.

Conditions

Low Molecular Weight Heparin; Recurrent Implantation Failure; FET; IVF

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

LMWH group

the LMWH group received injections of 4100 IU/d LMWH from the day of transplant

Low Molecular Weight Heparine

Intervention Type: DRUG

the LMWH group received injections of 4100 IU/d LMWH from the day of transplant

Control group

the control group received the routine luteal support protocol (without LMWH use)

No interventions assigned to this group

Interventions

Low Molecular Weight Heparine

the LMWH group received injections of 4100 IU/d LMWH from the day of transplant

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Second Hospital of Shandong University

OTHER

Sponsor Role: lead

Responsible Party

Linlin Cui

professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Second Hospital of Shandong University

Jinan, Shandong, China

Countries

China

Other Identifiers

KYLL2025342

Identifier Type: -

Identifier Source: org_study_id