Condition category
Pregnancy and Childbirth
Date applied
25/06/2008
Date assigned
25/07/2008
Last edited
30/07/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mona Aboulghar

ORCID ID

Contact details

The Egyptian IVF-ET Center
3
St. 161 Hadaek Al Maadi
Maadi
Cairo
11431
Egypt

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

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

Acronym

Study hypothesis

Treatment with progesterone is emerging as the standard of care for prevention of preterm delivery in women at high risk for preterm birth. Randomised controlled trials (RCTs) have generally shown efficacy in reducing the rate of recurrent preterm delivery in women with singleton pregnancies who were at high risk for preterm labour and delivery. Most of the successful trials have employed 17-alpha-hydroxyprogesterone caproate, and one trial has reported positive results using progesterone vaginal suppositories. Very few trials of progestogens have been reported for women at risk for preterm delivery because of multiple gestations.

Ethics approval

The Egyptian IVF-ET Center Ethics Committee. Date of approval: 17/06/2008 (ref: 4/2008)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Prevention of preterm labour after IVF/ICSI

Intervention

Intervention group: Natural progesterone will be administered in the form of natural ProntogestĀ® 400 mg daily through the vaginal route (pessaries). Progesterone administration will continue until delivery.
Control group: Standard care only

Serum progesterone will be measured at start of trial (20 weeks gestation) and at 32 weeks gestation in all participants.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Delivery <37 weeks' gestation.

Secondary outcome measures

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

Overall trial start date

01/07/2008

Overall trial end date

30/12/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

302

Participant 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

Recruitment start date

01/07/2008

Recruitment end date

30/12/2009

Locations

Countries of recruitment

Egypt

Trial participating centre

The Egyptian IVF-ET Center
Cairo
11431
Egypt

Sponsor information

Organisation

Marcyrl (Egypt)

Sponsor details

Habib Scientific Office
Buildings Sheraton Square No. 1227
Building No. 8C
Cairo
-
Egypt

Sponsor type

Industry

Website

http://www.marcyrl.com

Funders

Funder type

Hospital/treatment centre

Funder name

This trial is funded mainly by the Egyptian IVF-ET Center (Egypt). The cost of medication is funded by Institut Biochimique SA (IBSA; Egypt).

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes