Investigation into the effectiveness of progesterone prevention of preterm labour in women who became pregnant by in vitro fertilisation (IVF)/ intra-cytoplasmic sperm injection (ICSI)

Effect of progesterone administration on the duration of pregnancy after in vitro fertilisation (IVF)/ intra-cytoplasmic sperm injection (ICSI): a prospective randomised study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN06959967

Enrollment

302

Registered

2008-07-25

Start date

2008-07-01

Completion date

Unknown

Last updated

2015-01-13

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

Conditions

Prevention of preterm labour after IVF/ICSI Pregnancy and Childbirth Preterm labour

Interventions

Intervention group: Natural progesterone will be administered in the form of natural Prontogest® 400 mg daily through the vaginal route (pessaries). Progesterone administration will continue until del

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: Healthy women who became pregnant after IVF/ICSI (singleton or twin). Randomisation will be carried out, on average, during the 20th week of gestation.

Exclusion criteria

Exclusion criteria: 1. Rupture of membranes 2. Smokers 3. Major known foetal anomalies 4. Uterine anomalies 5. Cervical cerclage 6. Treatment during this pregnancy with progesterone after 12 weeks' gestation (use up to 10 weeks' gestation is permitted) 7. Contraindications to tocolysis, including foetal distress, chorioamnionitis, preeclampsia, hemodynamic instability 8. Patients treated with oral beta adrenergics for asthma 9. Age <18 years

Design outcomes

Primary

Measure	Time frame
Delivery <37 weeks' gestation.	—

Secondary

Measure	Time frame
1. Neonatal outcome 2. Incidence of prematurity 3. Admission to neonatal intensive care unit (ICU) 4. Complication of prematurity	—

Countries

Egypt

Outcome results

None listed

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