NCT07759609

Brief Summary

Unexplained pregnancy loss remains a major reproductive challenge, and effective management strategies for affected couples are limited. Although intrauterine insemination (IUI) is widely used in reproductive medicine, its effectiveness in improving subsequent pregnancy outcomes among couples with unexplained pregnancy loss has not been well established. This multicenter, open-label, randomized controlled trial aims to evaluate whether IUI improves subsequent pregnancy outcomes compared with natural conception in couples with unexplained pregnancy loss. A total of 558 eligible couples will be enrolled and randomly assigned to either an IUI group or a natural conception group. Participants will be followed to assess reproductive outcomes. The findings of this study are expected to provide high-quality evidence regarding the role of IUI in the management of unexplained pregnancy loss and to inform future clinical practice.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
558

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Jan 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress28%
Jan 2026Dec 2027

Study Start

First participant enrolled

January 27, 2026

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

August 12, 2026

Status Verified

January 1, 2026

Enrollment Period

1.8 years

First QC Date

July 23, 2026

Last Update Submit

August 6, 2026

Conditions

Unexplained Pregnancy Loss

Outcome Measures

Primary Outcomes (1)

  • Early Miscarriage Rate

    The proportion of women who experience pregnancy loss before 10 weeks of gestation among those achieving pregnancy.

    From randomization until 10 weeks of gestation

Secondary Outcomes (4)

  • Clinical Pregnancy Rate

    From randomization until clinical pregnancy assessment (6-8 weeks of gestation)

  • Live Birth Rate

    From randomization until delivery (approximately 40 weeks of gestation)

  • Preterm Birth Rate

    From randomization until delivery (approximately 40 weeks of gestation)

  • Adverse Event Rate

    From enrollment until completion of study follow-up (approximately 40 weeks of gestation)

Study Arms (2)

Natural Conception

NO INTERVENTION

Participants attempt natural conception without intrauterine insemination.

Intrauterine Insemination (IUI)

EXPERIMENTAL

Participants undergo intrauterine insemination after randomization to improve the probability of conception.

Procedure: Intrauterine Insemination (IUI)

Interventions

Intrauterine Insemination (IUI)PROCEDURE

Participants assigned to the intervention group undergo intrauterine insemination (IUI) according to the study protocol. Processed sperm is placed into the uterine cavity during the periovulatory period to improve the likelihood of conception.

Intrauterine Insemination (IUI)

Eligibility Criteria

Age20 Years - 37 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female participants aged 20-37 years.
  • History of at least one ultrasound-confirmed pregnancy loss (excluding biochemical pregnancy, ectopic pregnancy, and hydatidiform mole), with the most recent pregnancy loss occurring within the previous 12 months.
  • Desire for pregnancy at the time of enrollment.
  • Basal follicle-stimulating hormone (FSH) \<10 IU/L.
  • Anti-Müllerian hormone (AMH) \>1.1 ng/mL.
  • Male partner's semen analysis meeting the criteria for intrauterine insemination (IUI), with a post-processing total progressive motile sperm count ≥5 × 10⁶.
  • Ability and willingness to provide written informed consent.

You may not qualify if:

  • Congenital or acquired uterine structural abnormalities.
  • Thyroid dysfunction, defined as thyroid-stimulating hormone (TSH) \>4.0 mIU/L.
  • Positive antiphospholipid antibodies, including lupus anticoagulant, anticardiolipin antibodies, or anti-β2 glycoprotein I antibodies.
  • Parental chromosomal abnormalities or a history of fetal chromosomal abnormalities in a previous pregnancy.
  • Participation in another interventional clinical trial during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Beijing Amcare Beisanhuan Women's & Children's Hospital

Beijing, Beijing Municipality, China

NOT YET RECRUITING

Lanzhou university second hosipital

Lanzhou, Gansu, China

RECRUITING

Hebei Reproductive Health Hospital

Shijiazhuang, Hebei, China

NOT YET RECRUITING

Central Study Contacts

Fang Wang, PhD

CONTACT

+86 13919302888ery_fwang@lzu.edu.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lanzhou University Second Hospital

Study Record Dates

First Submitted

July 23, 2026

First Posted

August 12, 2026

Study Start

January 27, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

August 12, 2026

Record last verified: 2026-01

Locations

CN(3)