Prevention of multiple pregnancies in couples with unexplained or mild male subfertility

Treatment of couples with unexplained or mild male subfertility and an unfavorable prognosis. A randomised trial comparing the cost-effectiveness of IUI with ovarian hyperstimulation, manipulated natural cycle IVF and IVF with single embryo transfer.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON20581

Enrollment

600

Registered

2007-03-21

Start date

2007-07-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

delivery, pregnancy_outcome, pregnancy_multiple, insemination_artificial, fertilization_in_vitro, embryo_transfer, patient_preference

Interventions

The comparisons are six cycles of intra-uterine insemination with controlled ovarian hyperstimulation, six cycles of manipulated natural cycle IVF, and three cycles with IVF-eSET plus cryo-cycles with

Eligibility

Inclusion criteria

Inclusion criteria: Couples are eligible if the following apply: 1. Female age between 18 and 38 years. 2. Failure to conceive within at least 12 months of unprotected intercourse. 3. The couple has poor fertility prospects as calculated by the validated model of Hunault (Hunault et al., 2005; Van der Steeg et al., 2006). A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months.

Exclusion criteria

Exclusion criteria: Couples must not be entered if any of the following apply: 1. Polycystic ovary syndrome or any other anovulation. 2. Post-wash total motile sperm count below 3 million. 3. Double-sided tubal pathology. 4. Endocrinopathological disease like: Cushing syndrome, adrenal hyperplasia, hyperprolactinemia, acromegaly, imminent ovarian failure, premature ovarian failure, hypothalamic amenorrhea, hypothyroidy, diabetes mellitus type I. 5. Negative post-coitus test. 6. If not willing or able to sign the consent form.

Design outcomes

Primary

Measure	Time frame
Birth of a healthy child.	—

Secondary

Measure	Time frame
1. Multiple pregnancy, defined as registered heartbeat of at least two foetuses at 12 weeks of gestation; 2. Clinical pregnancy, defined as any registered embryonic heartbeat at sonography; 3. Neonatal mortality; 4. Pregnancy complications (preterm birth < 37 weeks, birth weight < 2.500 gram, Pregnancy Induced Hypertension (PIH), (pre-) eclampsia, HELLP); 5. Costs.	—

Contacts

Public ContactM.H. Mochtar

Academical Medical Center, Center for Reproductive Medicine

M.H.Mochtar@amc.uva.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)