Protocol summary
-
Study aim
-
Comparison of luteal phase stimulation with follicular phase stimulation in poor ovarian response
-
Design
-
Clinical trial with control group, with parallel groups, single-blind, randomized, phase 3 on 78 patients. Randomization will be done using 4 blocks designed with sealedenvelop.com software.
-
Settings and conduct
-
This study will be performed at Avicenna Infertility Center. Women are randomly divided into two groups.In the intervention group ovarian stimulation begins in the luteal phase and in the control group ovarian stimulation begins in the follicular phase. In both groups, GnRH antagonist is administered when the largest follicle is> 12 mm.
Stimulation of ovulation using a GnRH agonist with 2 HCGs when at least one follicle> 18 mm is seen will be prescribed. Oocyte collection will be done by transvaginal ultrasound 36 hours later.
Fertilization will take place after oocyte retrieval. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred.Pregnancy test is done14 days after embryo transfer. Chemical and clinical pregnancy rates will be assessed.
-
Participants/Inclusion and exclusion criteria
-
- History of an ovulation stimulation cycle with less than 4 oocytes
- AMH<1.1 ng/ml or AFC<5
- Total number of motile sperm at least 15 million
- Normal uterus in ultrasound hysterosalpingography
- Regular periods of 21-35 days
- Indication for IVF
- Compliance to participate and collaborate with study protocol
- Signing informed consent
-
Intervention groups
-
Intervention group: ovarian stimulation in the luteal phase will be started on days 15-16 of the cycle. Stimulation will be performed using HCG.
Control group: ovarian stimulation in the follicular phase is initiated at the beginning of the cycle. Stimulation will be performed using HCG.
-
Main outcome variables
-
Number of metaphase II oocytes
General information
-
Reason for update
-
The update is to change the sample size.
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210405050852N1
Registration date:
2021-06-10, 1400/03/20
Registration timing:
prospective
Last update:
2023-03-01, 1401/12/10
Update count:
1
-
Registration date
-
2021-06-10, 1400/03/20
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2021-07-01, 1400/04/10
-
Expected recruitment end date
-
2021-12-31, 1400/10/10
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Comparison of luteal phase stimulation with follicular phase stimulation in poor ovarian response
-
Public title
-
Effect of luteal phase stimulation with follicular phase stimulation in poor ovarian response
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
History of an ovulation stimulation cycle with less than 4 oocytes
AMH<1.1 ng/ml or AFC<5
The total number of motile sperm is at least 15 million
Normal uterus in ultrasound and hysterosalpingography
Regular periods of 21-35 days
Indication for IVF
Ability to participate and collaborate with study protocol
Signature informed consent
Under 40 years
Exclusion criteria:
History of ovarian surgery
History of pelvic cytotoxic radiation exposure due to malignancy
History of recurrent miscarriage
Grade III or IV endometriosis
Concomitant uterine pathology (adenomyosis, submucosal myoma, Asherman syndrome)
Autoimmune disease
-
Age
-
From 18 years old to 39 years old
-
Gender
-
Female
-
Phase
-
3
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
78
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
The Block randomization method was designed by an epidemiologist using STATA software version 13 and the number of blocks considered is 4. The random allocation list for patients was solely available to the epidemiologist. In order to hide the random allocation process, a total of 78 envelopes were prepared, and only the methodologist has been aware of the table of random numbers. When the doctor declared the patient's eligibility, the methodologist provided the doctor with the envelope. The group was selected based on the type of group mentioned in the envelope.
-
Blinding (investigator's opinion)
-
Single blinded
-
Blinding description
-
This is a single-blind study. The participants don't aware about grouping name and type of treatment in each group. In order to blind the patients participating in this study, all conditions will be the same between the two groups, so patients in the intervention and control groups will refer to the center on ovulation stimulation days in both groups.
-
Placebo
-
Not used
-
Assignment
-
Parallel
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2021-03-09, 1399/12/19
-
Ethics committee reference number
-
IR.ACECR.AVICENNA.REC.1400.002
Health conditions studied
1
-
Description of health condition studied
-
Poor ovarian response
-
ICD-10 code
-
E28
-
ICD-10 code description
-
Ovarian dysfunction
Primary outcomes
1
-
Description
-
Number of metaphase II oocyte
-
Timepoint
-
End of ovarian stimulation
-
Method of measurement
-
Observation of metaphase 2 oocytes extracted by the embryologist
Secondary outcomes
1
-
Description
-
Chemical pregnancy rate
-
Timepoint
-
14 days after transfer
-
Method of measurement
-
Beta-Human Chorionic Gonadotropin
2
-
Description
-
Clinical pregnancy
-
Timepoint
-
Pregnancy 7th weeks
-
Method of measurement
-
Detect of fetal heart beat on ultrasound
3
-
Description
-
Total number of embryos
-
Timepoint
-
After in vitro fertilization
-
Method of measurement
-
18-20 hours after in vitro fertilization
Intervention groups
1
-
Description
-
In this study, to compare the effect of luteal phase stimulation with follicular phase stimulation in patients with poor ovarian response, in the luteal phase group on days 15 to 16 of the menstrual cycle and when spontaneous ovulation is confirmed by transvaginal ultrasound and patients have one follicle at least 8 mm, start with 300 units of FSH plus 150 to 225 units of HMG plus 10 mg of medroxyprogesterone daily. Medroxyprogesterone is used to delay mensturation and stop the release of oocytes during mensturation. GnRH antagonist is given when the largest follicle is> 12 mm. Sono examination will be performed every 24 to 72 hours. Blood hormones will also be tested by checking estradiol and progesterone levels on the day of ovulation stimulation. Ovulation stimulation will be administered using a GnRH agonist with 2 Human chorionic gonadotropins when at least one follicle <18 mm is seen. Oocyte collection will be done by transvaginal ultrasound 36 hours later. Fertilization will take place after oocyte retrieval. Successful fertilization is diagnosed when two pronuclei are seen about 18-20 hours after insemination. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred. 14 days after the transfer of the fetus, the pregnancy test will be requested and the rate of chemical and clinical pregnancy will be evaluated.
-
Category
-
Treatment - Drugs
2
-
Description
-
Control group: In patients in the control group (follicular phase stimulation group), ovarian stimulation begins on the second or third day of the cycle with 300 units of FSH plus 150 to 225 units of HMG. GnRH antagonist is given when the largest follicle is> 12 mm. Ultrasound examination will be performed every 24 to 72 hours. Blood hormone analysis will also be done by checking estradiol and progesterone levels on the day of ovulation stimulation, and ovulation stimulation by GnRH agonist along with 2 Human chorionic gonadotropins will be administered when at least one follicle <18 mm is seen. Fertilization will take place after oocyte harvest. Successful fertilization is diagnosed when two pronuclei are seen about 18-20 hours after inoculation. The embryos are then frozen on the third or fifth day, and in another cycle, the uterus is prepared for embryo transfer and the embryos are transferred. 14 days after the transfer of the fetus, the pregnancy test will be requested and the rate of chemical and clinical pregnancy will be evaluated.
-
Category
-
Treatment - Drugs
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Avicenna University Jihad Infertility Center Avicenna
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
Yes - There is a plan to make this available
-
Data Dictionary
-
Undecided - It is not yet known if there will be a plan to make this available
-
Title and more details about the data/document
-
Comparison of luteal phase stimulation with follicular phase stimulation in poor ovarian response
-
When the data will become available and for how long
-
Up to one year after the publication of the article
-
To whom data/document is available
-
Other researchers and physicians
-
Under which criteria data/document could be used
-
Use in meta-analysis studies
-
From where data/document is obtainable
-
Avicenna infertility clinic, Dr. Mozhgan Vahabi datjerdi, 00982122644706
-
What processes are involved for a request to access data/document
-
Email to the responsible author, Dr. Mozhgan vahabi Dastjerdi
-
Comments
-