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Trial registered on ANZCTR


Registration number
ACTRN12614000715673
Ethics application status
Approved
Date submitted
21/06/2014
Date registered
7/07/2014
Date last updated
7/07/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Administering Gonadotrophin Releasing Hormone (GnRH) Agonists during the Luteal Phase in Artificial Cycle Frozen-Thawed Embryo Transfers
Scientific title
Effect of administering GnRH agonists during the luteal phase on ongoing pregnancy rate in women undergoing artificial cycle frozen-thawed embryo transfers
Secondary ID [1] 284850 0
none
Universal Trial Number (UTN)
U1111-1158-3033
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Frozen Thawed embryo transfers in Assisted Reproduction Technology 292244 0
Condition category
Condition code
Reproductive Health and Childbirth 292584 292584 0 0
Fertility including in vitro fertilisation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The aim of this study is to evaluate the benefit of
- two sub cutaneous injections of GnRH agonists (tryptorelin 0.1 mg) administred on the 4th day and on the 6th day following the introduction of progesterone
- In addition to usual progesterone supplementation (3 pills of 200 mg per day administred vaginally, 1 in the morning, 2 in the evening)

The oestradiol supplementation was starded on the first day of the cycle :
- From the first day to the 5th day of the cycle, they took 2 pills containing 2 mg of estradiol a day
-From the 6th to the 10th day of the cycle, they took 3 pills containing 2 mg of estradiol a day.
- They then took 4 pills containing 2 mg of estradiol a day
until the pregnancy test.
Oestrogen was first administered orally, then vaginally, following menstruation.

Test were performed on the 13th day (blood test and ultrasonography).

The progesterone was introduced when all conditions are met : The endometrium over 6 mm in thickness, pulsatility indexes below 3, and oestrogen levels above 750 pg/ml.
If these conditions weren’t met, a 2nd test and up to a 3rd test were conducted, where oestrogen doses could be increased (increasing the dose to 5 or 6 pills a day).

A pregnancy test (Human Chorionic Gonadotropin (HCG) assay) was conducted 16 days after the introduction of progesterone. Patients continued to take oestrogen and progesterone during the first three months of the pregnancy if this test was positive.
Intervention code [1] 289646 0
Treatment: Drugs
Comparator / control treatment
Control treatment : Usual progesterone supplementation (3 pills of 200 mg per day administred vaginally, 1 in the morning, 2 in the evening)

The oestradiol supplementation was starded on the first day of the cycle :
- From the first day to the 5th day of the cycle, they took 2 pills containing 2 mg of estradiol a day
-From the 6th to the 10th day of the cycle, they took 3 pills containing 2 mg of estradiol a day.
- They then took 4 pills containing 2 mg of estradiol a day
until the pregnancy test.
Oestrogen was first administered orally, then vaginally, following menstruation.

Test were performed on the 13th day (blood test and ultrasonography).

The progesterone was introduced when all conditions are met : The endometrium over 6 mm in thickness, pulsatility indexes below 3, and oestrogen levels above 750 pg/ml.
If these conditions weren’t met, a 2nd test and up to a 3rd test were conducted, where oestrogen doses could be increased (increasing the dose to 5 or 6 pills a day).

A pregnancy test (HCG assay) was conducted 16 days after the introduction of progesterone. Patients continued to take oestrogen and progesterone during the first three months of the pregnancy if this test was positive.
Control group
Active

Outcomes
Primary outcome [1] 292441 0
The primary outcome was the ongoing pregnacy rate. This was the number of pregnancies that continue beyond the first trimester obstetrical ultrasound, out of 100 Frozen Thawed Embryo Transfers.
Timepoint [1] 292441 0
The first trimester obstetrical ultrasound (around the 12th week on pregnancy)
Secondary outcome [1] 308951 0
The secondary outcome was the implantation rate. It was defined by the number of gestational sacs that contain embryos with cardiac activity, divided by the number of transferred embryos.
Timepoint [1] 308951 0
A obstrtrical ultrasound around 6 weeks of pregnancy

Eligibility
Key inclusion criteria
All patients undergoing artificial cycle of Frozen Thawed Embryo Transfers in our Assisted Reproduction Technology' s center
Minimum age
18 Years
Maximum age
43 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Frozen Thawed Embryo Transfers resulting from oocyte or embryo donations

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Efficacy
Statistical methods / analysis
Sample-size calculation was based on the observed differences in pregnancy rate from existing literature in FIV/ICSI treatment. For a difference of 5% on ongoing pregnancy rate, for a power of 90% and an alpha of 5%, 90 women needed to be recruited into each arm. We estimated dropout rates to range between 10 and 20 %, so 220 women were randomized.
The SPSS 17.0 software (IBM, Chicago, IL, USA) was used to conduct a statistical analysis of the results. The discrete variables were compared using a Chi square test. Continuous quantitative variables were expressed as their average and standard deviation. They were compared using a t-test, a paired t-test or an analysis of variance, when 2 factors were being considered. Multivariate analyses were done using logistic regressions or decision tree hierarchical classifications with the CHAID method. A test was considered to be significant when p was less than 0.05.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2012
Actual
1/10/2012
Date of last participant enrolment
Anticipated
30/06/2013
Actual
30/06/2013
Date of last data collection
Anticipated
Actual
Sample size
Target
220
Accrual to date
Final
Recruitment outside Australia
Country [1] 6170 0
France
State/province [1] 6170 0
Rhone Alpes

Funding & Sponsors
Funding source category [1] 289459 0
Hospital
Name [1] 289459 0
hopital Femme Mere Enfant
Country [1] 289459 0
France
Primary sponsor type
Hospital
Name
Hopital Femme Mere Enfant
Address
Service de Medecine de la Reproduction
59 Boulevard Pinel
69500 BRON
Country
France
Secondary sponsor category [1] 288146 0
University
Name [1] 288146 0
Faculte de Medecine Lyon Est
Address [1] 288146 0
8, Avenue ROCKEFELLER
69373 LYON CEDEX 08
Country [1] 288146 0
France

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291218 0
Espace Ethique Rhone Alpes
Ethics committee address [1] 291218 0
Ethics committee country [1] 291218 0
France
Date submitted for ethics approval [1] 291218 0
Approval date [1] 291218 0
20/09/2012
Ethics approval number [1] 291218 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 49382 0
Dr Melisanda Gogce
Address 49382 0
Service de Medecine de la Reprodcution
Hopital Femme Mere Enfant
59 boulevard Pinel
69500 Bron
Country 49382 0
France
Phone 49382 0
+33 427855531
Fax 49382 0
Email 49382 0
melisanda.gogce@chu-lyon.fr
Contact person for public queries
Name 49383 0
Bruno Salle
Address 49383 0
Service de Medecine de la Reproduction
Hopital Femme Mere Enfant
59 boulevard Pinel
69500 Bron
Country 49383 0
France
Phone 49383 0
+33 472129412
Fax 49383 0
Email 49383 0
bruno.salle@chu-lyon.fr
Contact person for scientific queries
Name 49384 0
Melisanda Gogce
Address 49384 0
Service de Medecine de la Reprodcution
Hopital Femme Mere Enfant
59 boulevard Pinel
69500 Bron
Country 49384 0
France
Phone 49384 0
+33 427855531
Fax 49384 0
Email 49384 0
melisanda.gogce@chu-lyon.fr

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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