Comparison of delayed start GNRH antagonist protocol and usual antagonist protocol in oocyte count and pregnancy rate in ART cycle in poor ovarian responders
The objective of this study is evaluating the effect of delayed start protocol in ovarian poor responders. Study population: Infertile women with poor ovarian response candidate for IVF. Study groups: Intervention and control groups. There are thirty women in intervention group and thirty in control group. This is a randomized not blinded trail, in one center, in phase 2 study. Setting and conduct: Ovarian poor responders after obtaining informed consent randomized into intervention and control groups. Inclusion criteria: Patient with Bologna criteria for ovarian poor responders.
Exclusion criteria: History of endocrine disorders, severe endometriosis, azoospermia. Control group treated with conventional antagonist protocol and intervention group with delayed protocol. Pretreatment with 4mg estradiol valerate was administered in both groups. In the delayed-start protocol, ovarian stimulation begins after 7 days of GnRH antagonist pretreatment (0.25 mg cetrorelix acetate). Ovarian stimulation with 375 IU FSH administered for both groups.
GnRH antagonist will prevent premature ovulation when the lead follicle measured 12 mm and continued until the hCG trigger. Final oocyte maturation will trigger with 10,000 IU hCG. Oocyte retrieval performs under transvaginal ultrasound guidance 34-36 hours after hCG triggering. Intracytoplasmic sperm injection (ICSI) performed with mature oocytes (metaphase II [MII]) in all cycles. Embryos will transfer 2 or 3 days after oocyte retrieval. Primary outcomes: Number of mature oocytes(MII) , total number of oocytes. Secondary outcomes: Number of embryo, fertilization rate, implantation rate, chemical and clinical pregnancy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015100424335N1
Registration date:2016-01-18, 1394/10/28
Registration timing:retrospective
Last update:
Update count:3
Registration date
2016-01-18, 1394/10/28
Registrant information
Name
robabe hoseinisadat
Name of organization / entity
infertility institute center of shahid sadughi
Country
Iran (Islamic Republic of)
Phone
+98 35 3824 7085
Email address
robabehoseini@ssu.ac.ir
Recruitment status
Recruitment complete
Funding source
Shahid Sadoughi University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of delayed start GNRH antagonist protocol and usual antagonist protocol in oocyte count and pregnancy rate in ART cycle in poor ovarian responders
Public title
Effect of delayed start protocol in outcome of
ART cycle in poor ovarian responders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Poor ovarian responders according to Bologna criteria. At least two of the following three features must be present:
1. Advanced maternal age (≥40 years) or any other risk factor for poor ovarian response;
2. A previous poor ovarian response (≤3 oocytes with a conventional stimulation protocol);
3. An abnormal ovarian reserve test (i.e. AFC <5–7 follicles or AMH <1.1 ng/ml).
Two episodes of POR after maximal stimulation are sufficient to define a patient as poor responder.
Exclusion criteria: History of endocrine and metabolic disorders, endometriosis, azoospermia.
Age
From 18 years old to 45 years old
Gender
Female
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomized with enveloped pocket method
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Sadoughi University of Medical Sciences
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Approval date
2015-06-07, 1394/03/17
Ethics committee reference number
148
Health conditions studied
1
Description of health condition studied
Infertility
ICD-10 code
N98.9
ICD-10 code description
Complication associated with artificial fertilization, unspecified
Primary outcomes
1
Description
Mature oocytes count
Timepoint
Oocyte retrieval day
Method of measurement
Counting number of mature oocytes with microscope
2
Description
total oocytes count
Timepoint
oocyte retrieval day
Method of measurement
counting number of total oocytes with microscope
Secondary outcomes
1
Description
Number of embryo
Timepoint
2th day after ICSI
Method of measurement
Observation with microscope
2
Description
Chemical pregnancy
Timepoint
14 days after embryo transfer
Method of measurement
Serum βhCG
3
Description
clinical pregnancy
Timepoint
3 weeks after positive serum βhCG
Method of measurement
vaginal ultrasonography
Intervention groups
1
Description
In intervention group 0/25 mg/vial cetrorelix( GNRH antagonist), one vial daily, subcutaneous, for 7 days, before starting COH
Category
Treatment - Drugs
2
Description
in control group patients treated with antagonist protocol without GNRH antagonist pretreatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Clinical Center for Infertility, Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
Full name of responsible person
Abass Aflatoonian
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Shahid Sadoughi University of Medical Sciences
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
Sadoughi University of Medical Sciences ,Yazd
Full name of responsible person
Robabe Hosseinisadat
Position
Student of infertility felowship
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
robabehosseinisadat@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Sadoughi University of Medical Sciences
Full name of responsible person
Abbas Aflatoonian
Position
Professor
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
abbas_aflatoonian@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Sadoughi University of Medical Sciences
Full name of responsible person
Robabe Hosseinisadat
Position
Student of infertility felowship
Other areas of specialty/work
Street address
Research and Clinical Center for Infertility, Bouali, Timsar Fallahy, Safayeh, Yazd
City
Yazd
Postal code
8916877391
Phone
+98 35 3824 7085
Fax
+98 35 3824 7087
Email
robabehosseinisadat@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)