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Dydrogesterone or micronized progesterone related birth defects in children

Congenital anomalies in children following maternal use of dydrogesterone or micronized progesterone as luteal support in infertile women: A retrospective, observational study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ISRCTN
Registry ID
ISRCTN55659103
Enrollment
6298
Registered
2019-01-11
Start date
2002-01-08
Completion date
Unknown
Last updated
2019-08-26

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

Conditions

Infertility, luteal phase support Pregnancy and Childbirth

Interventions

A total number of 6537 women reporting for infertility treatment were screened for the present study. A total of 239 women with adenomyosis, congenital uterine anomalies and uterine synechiae, baselin

Sponsors

Institute of Reproductive Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Female 2. Aged 21-45 years 3. Primary and secondary infertility (e.g. ovulatory and hormonal disorders, fallopian tube obstruction, endometriosis and having partners with male factor infertility)

Exclusion criteria

Exclusion criteria: 1. Adenomyosis 2. Congenital uterine anomalies 3. Uterine synechiae 4. Baseline FSH >12 IU 5. Donor oocyte recipients 6. Gestational surrogates

Design outcomes

Primary

MeasureTime frame
1. Congenital anomalies detected during pregnancy or following birth 2. Functional abnormality

Secondary

MeasureTime frame
1. Pregnancy rate 2. Miscarriage rate 3. Intrauterine fetal outcome (including gestational age) 4. Intrauterine growth restriction (IUGR) 5. Intrauterine fetal death (IUFD) 6. Neonatal characteristics including number of live births, body weight, APGAR score, neonatal intensive care unit (NICU) admission, respiratory distress syndrome (RDS), neonatal jaundice, hypoglycaemia and hypocalcaemia.

Countries

India

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026