Estradiol valerate pretreatment in short protocol GnRH-agonist cycles versus combined pretreatment with oral contraceptive pills in long protocol GnRH-agonist cycles: a randomised controlled trial
The aim of our study was to compare the differences in pregnancy rates (PRs), implantation rates and miscarriage rates between a short agonist protocol with estradiol priming and a long protocol with combined OC. The inclusion criteria were as follows: women younger than 40 years old; an AMH level greater than 0.6 ng/mL; a body mass index between 18 and 29 kg/m2; and undergoing a first or second treatment cycle of IVF with intracytoplasmic sperm injection (ICSI). The exclusion criteria were endometriosis and preimplantation diagnosis cycles.
After providing written consent, the 298 participants were randomly divided into one of the two study groups (154 patients who were treated with long GnRH agonist with combined OC pretreatment and 144 who weretreated with short GnRH agonist with estradiol pretreatment). The doctors performing the oocyte retrieval procedure and the embryologists involved were blind to the treatment groups. Our primary outcome measure was clinical pregnancy rate.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015020418202N4
Registration date:2015-02-27, 1393/12/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-27, 1393/12/08
Registrant information
Name
Judyta Zabielska
Name of organization / entity
Invicta Sp.z o.o.
Country
Poland
Phone
0048 516 829 691
Email address
zabielska@gumed.edu.pl
Recruitment status
Recruitment complete
Funding source
Invicta sp.z o.o.
Expected recruitment start date
2013-07-01, 1392/04/10
Expected recruitment end date
2014-01-01, 1392/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Estradiol valerate pretreatment in short protocol GnRH-agonist cycles versus combined pretreatment with oral contraceptive pills in long protocol GnRH-agonist cycles: a randomised controlled trial
Public title
Comparison of short agonist vs long agonist stimulation protocol and different pretreatment s in women undergoing in vitro fertlization.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:
women younger than 40 years old;
an AMH level greater than 0.6 ng/mL;
a body mass index between 18 and 29 kg/m2;
first or second treatment cycle of IVF with intracytoplasmic sperm injection (ICSI).
Exclusion:
endometriosis;
preimplantation diagnosis cycles
Estradiol valerate pretreatment (2mg oral estradiol twice daily from the 20th day of cycle until 1-4th day of new cycle. in short protocol GnRH-agonist cycles (150-225 IU/day hMG continued with a daily dose of triptorelin 0.1 mg until the hCG injection - Chpragon 5000 administered 36 hours before retrieval.)
Category
Treatment - Drugs
2
Description
Combined pretreatment with oral contraceptive pills (Ovulostan from 2nd to 4th day of cycle) in long protocol GnRH-agonist cycles ( 0.1 mg Triptorelin beginning on the 14th day of the cycle, every 2 days, for two weeks, 150-225 IU/day hMG continued with a daily dose of triptorelin 0.1 mg until the hCG injection - Chpragon 5000 administered 36 hours before retrieval.)
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Invicta Fertility and Reproduction Centre
Full name of responsible person
Judytra Zabielska
Street address
City
Gdansk, Warsaw, Slupsk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Invicta Fertility and Reproduction Centre sp.z o.o.
Full name of responsible person
Judyta Zabielska
Street address
Trzy lipy 3
City
Gdansk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Invicta Fertility and Reproduction Centre sp.z o.o.
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Invicta Fertility and Reproduction Centre sp.z o.o.
Full name of responsible person
Judyta Zabielska
Position
assistant
Other areas of specialty/work
Street address
Trzy lipy 3
City
Gdansk
Province
Gdansk
Postal code
Phone
0048585858800
Fax
Email
judyta.zabielska@invicta.pl
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Invicta Fertility and Reproduction Centre sp.z o.o.
Full name of responsible person
Judyta Zabielska
Position
assistant
Other areas of specialty/work
Street address
Trzy lipy 3
City
Gdansk
Province
Gdansk
Postal code
Phone
0048585858800
Fax
Email
judyta.zabielska@invicta.pl
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Invicta Fertility and Reproduction Centre sp. z o.o.
Full name of responsible person
Judyta Zabielska
Position
assistant
Other areas of specialty/work
Street address
Trzy lipy 3
City
Gdansk
Province
Postal code
80-172
Phone
0048 58 58 58 800
Fax
Email
judytazabielska@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)