Female infertility : Management of immunologic infertility due to anti-sperm antibodies associated with bacterial vaginosis in the resource-limited context of KISANGANI in the Democratic Republic of Congo.

Efficacy of the combination of antimicrobial therapy with immunomodulators in the management of immunologic female infertility due to anti sperm antibody associated to bacterial vaginosis : Double-blind randomized controlled trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

PACTR

Registry ID

PACTR202410672612184

Enrollment

Registered

2024-10-08

Start date

2023-08-01

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Fertility-female

Interventions

Vagiklin forte

Metronidazole suppository

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Infertile (no clinical pregnancy after 12 moths of cohabitation) Good overall physical and mental health Confirmed HIV-negative and non-pregnant, Diagnosed with BV (Nugent score 7–10 and/or by modified Amsel criteria) No antibiotics, contraceptives or vaginal medication in the last 10 days Informed consent form signed Have an ovulatory cycle (24-32 days) Have at least one functional uterine tube Have no fibroid Have a partner with a normal sperm analysis (WHO 2010 criteria)

Exclusion criteria

Exclusion criteria: Withdrawal of consent during study Allergy to one of medicine used Not bringing proof that products have been used Not responding to at least 2 successive appointments

Design outcomes

Primary

Measure	Time frame
Conception;reduction in vaginal pH and BV using the Amsel and Nugent scores;negativation of anti sperm antibody	—

Secondary

Measure	Time frame
the tolerance of different interventions;quality of cervical mucus	—

Countries

Democratic Republic of the Congo

Contacts

Public ContactJUAKALI SKV

Academic Secretary General of the university of kisangani

drjuakali@gmail.com00243998505796

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026