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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON30790
Enrollment
600
Registered
2007-07-12
Start date
2007-08-01
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

unexplained subfertility and mild male subfertility

Interventions

INTERVENTIONS: Group A- 6 cycles intra-uterine insemination with controlled ovarian hyperstimulation. Group B - 6 cycles MNC-IVF followed by IVF-eSET. Group C - 3 cycles of IVF-eSET plus cryo-cycles

Sponsors

Academisch Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 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., 2007). A poor fertility prospect is defined as a chance of spontaneous pregnancy below 30% within 12 months.

Exclusion criteria

Exclusion criteria: 1. 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

MeasureTime frame
Primary outcome is the birth of a healthy child.

Secondary

MeasureTime frame
Secondary outcomes are singleton and multiple ongoing pregnancy rates, clinical pregnancy rate, neonatal and maternal complications, patient preference and costs.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)