NCT02739516

Brief Summary

The objective of this study was to evaluate the outcome of follicle stimulating hormone (FSH) co-administration with human chorionic gonadotrophins trigger for women with unexplained infertility (UEI) and assigned for letrozole (LTZ) stimulated intrauterine insemination (IUI) cycles .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
108

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2014

Shorter than P25 for phase_3

Status
completed

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 Start

First participant enrolled

June 1, 2014

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 15, 2016

Completed
Last Updated

May 19, 2016

Status Verified

May 1, 2016

Enrollment Period

1.2 years

First QC Date

March 14, 2016

Last Update Submit

May 17, 2016

Conditions

Unexplained Infertility

Outcome Measures

Primary Outcomes (1)

  • Clinical pregnancy rate per cycle (PR/C) and per woman (PP/W)

    Achievement of clinical pregnancy defined as the presence of an intrauterine gestational sac with a pulsating fetal heart beat on ultrasound

    Throughout the study completion; up to 3 months

Secondary Outcomes (3)

  • Frequency of ovarian hyperstimulation syndrome (OHSS)

    Throughout the study completion; up to 3 months

  • Multiple pregnancies

    Throughout the study completion; up to 3 months

  • The live birth rate per woman (LB/W).

    Throughout the study completion; up to 2 year

Study Arms (2)

Control

ACTIVE COMPARATOR

In letrozole stimulated cycle: On the day of ovulation trigger the patient received standard dose of Human chorionic gonadotropin (10,000 IU).

Drug: Human chorionic gonadotropinDrug: Letrozole

Study

EXPERIMENTAL

In letrozole stimulated cycle: On the day of ovulation trigger the patient received hCG 10000 IU plus FSH co-trigger (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once .

Drug: Human chorionic gonadotropinDrug: FSH co-triggerDrug: Letrozole

Interventions

Human chorionic gonadotropinDRUG

In letrozole stimulated cycle; Human chorionic gonadotropin ( hCG) 10000 IU was given intramuscular when the mean ovarian follicle diameter was ≥18 mm.

ControlStudy
FSH co-triggerDRUG

In letrozole stimulated cycle; FSH (urofollitropin; Fostimon, IBSA, Bazel, Swiz; 75 IU amp) 150 IU injected once intramuscular when the mean ovarian follicle diameter was ≥18 mm.

Study
LetrozoleDRUG

Letrozole oral tablets (Femara 2.5 mg tablet; Novartis Pharma Services, Switzerland) 2.5 mg tab twice daily for 5 days from cycle day 3.

ControlStudy

Eligibility Criteria

Age18 Years - 35 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Unexplained infertility for more than 2 years
  • Normal ovulation proved by midluteal serum progesterone level \>5 ng/ml,
  • Patent fallopian tubes confirmed by hysterosalpingography or laparoscopy
  • Normal semen analysis according to the modified World Health Organization (WHO) criteria
  • Normal hormonal profile (FSH, LH, prolactin and TSH) in the early follicular phase.

You may not qualify if:

  • Other causes of infertility ( tubal factors, polycystic ovary syndrome (PCOS), endometriosis)
  • Ovarian cysts,
  • FSH \>10 mIU/ml.
  • Previous intrauterine insemination (IUI )cycles,
  • Liver or kidney diseases,
  • Hypersensitivity to the used medications.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Chorionic GonadotropinLetrozole

Intervention Hierarchy (Ancestors)

GonadotropinsPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPlacental HormonesPeptidesAmino Acids, Peptides, and ProteinsPregnancy ProteinsProteinsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Ahmed Walid Anwar Murad, MD

    Gynecology & Obstetric Department, Faculty of Medicine, Benha University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, Department of Obstetrics and Gynecology, Faculty of Medicine, Benha University

Study Record Dates

First Submitted

March 14, 2016

First Posted

April 15, 2016

Study Start

June 1, 2014

Primary Completion

August 1, 2015

Study Completion

August 1, 2015

Last Updated

May 19, 2016

Record last verified: 2016-05