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New Protocol in Unexplained Infertility

NCT04754243 — Phase 4, Unknown, 200 participants, Tanta University

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A Higher Ovulation and Pregnancy Rates in Patients With Unexplained Infertility After Application of ANTIUI Protocol: A Randomized Multicenter Controlled Study

RegistryNCT04754243
StatusUnknown
PhasePhase 4
Study typeInterventional; randomized, parallel, masking: none, treatment
Enrollment200 (Estimated)
SponsorTanta University (Other)
ConditionsUnexplained Infertility
InterventionsGonadotropin, Standard protocol in IUI (Drug)
Datesstart 2021-03-01, primary completion 2024-12-31 (estimated), completion 2024-12-31 (estimated), first posted 2021-02-15, last updated 2023-07-18
Locations1 site in Egypt

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-Summary

The new protocol ANTIUI provides good results regarding ovulation and pregnancy rates in patients with unexplained infertility

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+Detailed description

Patients with unexplained infertility has normal investigations regarding hormonal, structural data. Semen is normal but no pregnancy occurs.

Before trying ICSI, we could help these patients with ANTIUI

+Arms and interventions

ArmTypeInterventionsDescription
Study groupExperimentalDrug: GonadotropinWill receive ANTIUI protocol
Control groupActive comparatorDrug: Standard protocol in IUIWill receive standard protocol in IUI and unexplained infertility
  • Gonadotropin (Drug): Giving patients gonadotropins and antagonist cetrotide
  • Standard protocol in IUI (Drug): Giving patients gonadotropins without antagonist cetrotide

+Outcome measures

Primary outcomes

  • Ovulation [6 months]: Disappearance of mature follicle
  • Pregnancy [6 months]: Number of pregnant cases

+Eligibility

Sex: Female, ages: 20 Years to 35 Years

Inclusion Criteria:

* Unexplained infertility
* Duration less than 5 years
* Good ovarian reserve AMH> 1.1
* Normal patent tubes
* No previous trials of IUI with the same protocol

Exclusion Criteria:

* Age > 35 years
* Duration of infertility> 5 years
* Abnormal semen
* Hypoplastic tubes
* prior failed ICSI

+Locations (1)

FacilityCityCountryStatus
Ayman Shehata DawoodTanta, Gharbia GovernorateEgyptRecruiting

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