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

Universitair Ziekenhuis Brussel

Status and phase: Unknown; Phase 4

Conditions: Infertility

Treatments: Other: Drug: Follitropine Bèta

Study type: Interventional

Funder types: Other

Identifiers

NCT01992731

IUI versus IVF/ICSI

Details and patient eligibility

About

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

Full description

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.

Enrollment: 138 estimated patients

Sex: Female

Ages: 38 to 42 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

IUI group

Active Comparator group

Description:

Group 1: Patients undergo a standard treatment with 3 consecutive gonadotrophin stimulated IUI cycles Intervention: treatment choice and drug:(Follitropine Bèta, Puregon, MSD). vs.

Treatment:

Other: Drug: Follitropine Bèta

IVF/ICSI arm

Active Comparator group

Description:

Group 2: 1 Patients start immediately with IVF/ICSI instead of IUI. A standard antagonist protocol with treatment with a recombinant FSH (Follitropine Bèta, Puregon, MSD) is used. Intervention: treatment choice and drug: recombinant FSH (Follitropine Bèta, Puregon,

Treatment:

Other: Drug: Follitropine Bèta