NCT05670795

Brief Summary

The aim of study is to evaluate the results of two different protocols for ovulation induction during IUI cycles. All patients undergo IUI cycles are randomly divided in to two groups. the first group is recombinant follicle stimulating hormone and the second group is the combination of recombinant follicle stimulating hormone with clomiphene citrate.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
254

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 4, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2024

Completed
Last Updated

February 2, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

January 2, 2023

Last Update Submit

January 31, 2024

Conditions

Infertility Unexplained

Keywords

ovulation inductioniui

Outcome Measures

Primary Outcomes (1)

  • Rate of clinical pregnancy

    after iui betahcg levels blood sampling

    day 15

Secondary Outcomes (1)

  • Rate of ongoing pregnancy

    Months 3

Study Arms (2)

recombinant follicle stimulating hormone

EXPERIMENTAL

Gonal-f® (75 I.U., Merck Serono, Darmstadt, Germany)

Drug: Recombinant Follicle Stimulating Hormone

recombinant follicle stimulating hormone and clomiphene citrate

ACTIVE COMPARATOR

Gonal-f® (75 I.U., Merck Serono, Darmstadt, Germany) Klomen® (50 mg, Koçak Farma, Tekirdag, Turkey)

Drug: Recombinant Follicle Stimulating Hormone and Clomiphene Citrate

Interventions

Recombinant Follicle Stimulating HormoneDRUG

clinical pregnancy rates

recombinant follicle stimulating hormone
Recombinant Follicle Stimulating Hormone and Clomiphene CitrateDRUG

clinical pregnancy rates

recombinant follicle stimulating hormone and clomiphene citrate

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • years old female
  • Unexplained infertility
  • Regular menstrual cycle
  • Bilateral tubal patency in HSG and normal uterine cavity
  • Total motile sperm count greater than 10 million/ml

You may not qualify if:

  • History of ovarian surgery
  • Uncorrected uterine pathology
  • Other endocrine diseases (thyroid, prolactin, hypogonadotropic hypogonadism)
  • Presence of a cyst greater than 10 mm on USG in 2-3 days of the period
  • Stage 3-4 endometriosis
  • TMSS \< 5 million/ml on the insemination day
  • Conditions where rFSH and clomiphene citrate are contraindicated

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Peeraer K, Debrock S, De Loecker P, Tomassetti C, Laenen A, Welkenhuysen M, Meeuwis L, Pelckmans S, Mol BW, Spiessens C, De Neubourg D, D'Hooghe TM. Low-dose human menopausal gonadotrophin versus clomiphene citrate in subfertile couples treated with intrauterine insemination: a randomized controlled trial. Hum Reprod. 2015 May;30(5):1079-88. doi: 10.1093/humrep/dev062. Epub 2015 Mar 18.

    PMID: 25788569BACKGROUND

  • Erdem M, Abay S, Erdem A, Firat Mutlu M, Nas E, Mutlu I, Oktem M. Recombinant FSH increases live birth rates as compared to clomiphene citrate in intrauterine insemination cycles in couples with subfertility: a prospective randomized study. Eur J Obstet Gynecol Reprod Biol. 2015 Jun;189:33-7. doi: 10.1016/j.ejogrb.2015.03.023. Epub 2015 Mar 28.

    PMID: 25855325BACKGROUND

  • Dankert T, Kremer JA, Cohlen BJ, Hamilton CJ, Pasker-de Jong PC, Straatman H, van Dop PA. A randomized clinical trial of clomiphene citrate versus low dose recombinant FSH for ovarian hyperstimulation in intrauterine insemination cycles for unexplained and male subfertility. Hum Reprod. 2007 Mar;22(3):792-7. doi: 10.1093/humrep/del441. Epub 2006 Nov 16.

    PMID: 17110396BACKGROUND

MeSH Terms

Interventions

Glycoprotein Hormones, alpha SubunitClomiphene

Intervention Hierarchy (Ancestors)

Chorionic GonadotropinGonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsFollicle Stimulating HormoneGonadotropins, PituitaryLuteinizing HormonePituitary Hormones, AnteriorPituitary HormonesThyrotropinPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsStilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Central Study Contacts

Pinar Ozcan, MD,PhD

CONTACT

+902124531700drpinarozcan@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 2, 2023

First Posted

January 4, 2023

Study Start

January 1, 2023

Primary Completion

May 1, 2024

Study Completion

May 1, 2024

Last Updated

February 2, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)