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Effect of hydroxychloroquine sulfate on pregnancy outcomes in patients with repeated implantation failure and ANA positive: a double-blind, randomized, placebo-controlled trial

Effect of hydroxychloroquine sulfate on pregnancy outcomes in patients with repeated implantation failure and ANA positive: a double-blind, randomized, placebo-controlled trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068839
Enrollment
Unknown
Registered
2023-03-01
Start date
2023-03-01
Completion date
Unknown
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

patients with repeated implantation failure and ANA positive

Interventions

Hydroxychloroquine sulfate group:Hydroxychloroquine sulfate

Sponsors

peking university third hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Patients who failed to obtain clinical pregnancy after at least 2 fresh or freeze-thaw embryo transfer cycles and at least 2 high-quality cleavage embryos or 1 high-quality blastula each time 2. ANA titer >= 1:80 was detected by indirect immunofluorescence at least 4 weeks interval >=2 times; 3. IVF treatment was performed at the reproductive center for the second pregnancy.

Exclusion criteria

Exclusion criteria: 1. Abnormal anatomical structure of reproductive system, hydrosalpinx, adenomyosis of uterus, interwall fibroids with fibroids >4cm in diameter and submucosal fibroids; 2. Chromosomal abnormalities of both spouses or one spouse; 3. There are other definite autoimmune diseases; 4. Anti-phospholipid antibody [including aCL antibody (IgG, IgM, IgA, chemiluminescence assay), anti-ß2Gpi antibody (IgG, IgM, IgA, chemiluminescence assay), aPS/PT antibody (IgG, IgM, chemiluminescence assay), LA (coagulation assay)] positive; 5. Women who are currently receiving pharammine, Exel, supraline, Android, any corticosteroid hormone or immunosuppressant, such as prednisone, cyclosporine, and azathioprine, require a corresponding washout period before screening. Such as faammine (within 30 hours), Exai (within 42 hours), Suprillin (within 21 hours), Android (within 126 hours), glucocorticoid (within 18 hours); 6. Possible contraindications of hydroxychloroquine with fundus macular disease or visual field defect; 7. Known past allergy to hydroxychloroquine; 8. Endometrium <7mm before transplantation; 9. There are assisted reproductive technologies or/and medical contraindications to pregnancy and/or there are contraindications to assisted pregnancy; 10. Non-high-quality embryos (high-quality embryos are defined as: Grade I or II D3 cleavage stage embryos, blastocyst stage embryos 4BC or above) 11. ? the age of 40.

Design outcomes

Primary

MeasureTime frame
clinicalpregnancy;

Secondary

MeasureTime frame
hCG positive rate;Early abortion rate;Sustained pregnancy rate;

Countries

China

Contacts

Public ContactWang Haiyan

peking university third hospital

wangquan1991@sina.com+86 136 6131 9838

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026