IUI vs. IVF/ICSI in Women Aged 38-42 Years: a Prospective Randomized Controlled Trial.

Phase 4UnknownNCT01992731

Universitair Ziekenhuis Brussel138 enrolled

Overview

Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years.

Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. . Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

138

Conditions

Infertility

Interventions

Drug: Follitropine BètaOTHER

Eligibility

Sex: FEMALEMin age: 38 YearsMax age: 42 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: Women aged between 38 and 42 years. Sperm: use of donor sperm or husband sperm reaching WHO criteria 2010. Exclusion Criteria: * Tubal infertility (even one tube). * Major uterine or ovarian abnormalities * Metabolic abnormalities

Locations (1)

UniversitairZB

Jette, Belgium

RECRUITING

Outcomes

Primary Outcomes

Ongoing pregnancy rate

Study design: Prospective randomised controlled trial: 3 IUI cycles versus 1 IVF/ICSI cycle in women aged 38-42 years. Group 1: 3 consecutive gonadotrophin stimulated IUI cycles (Follitropine Bèta, Puregon, MSD). vs. Group 2: 1 IVF/ ICSI cycle - Recombinant FSH (Follitropine Bèta, Puregon, MSD) - Antagonist protocol. Primary endpoint: Comparison of the cumulative ongoing pregnancy rates after 3 IUI cycles versus 1 IVF/ICSI cycle.

Time frame: 12 weeks

Data from ClinicalTrials.gov

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