Comparison of Hormone replacement therapy with mild ovarian stimulation as endometrial preparation protocols for frozen-thawed embryo transfer in polycystic ovarian syndrome
Comparison between the effectiveness of letrozole and hormone replacement therapy in frozen embryo transfer technique in polycystic ovarian syndrome (PCOS)
Design
This is a randomized controlled trial on 130 infertile women with polycystic ovary syndrome (PCOS) who underwent invitro fertilization (IVF) or itracytoplasmic sperm injection (ICSI) and frozen embryo transfer. The eligible patients will be randomly allocated into two groups: stimulated cycle with letrozole and human menopausal gonadotropin (HMG; intervention group) and routine artificial hormonal endometrial preparation (control group). The permuted block randomization will be conducted according to a computer-generated list. The patients’ enrolment and assignment to groups will be carried out by a researcher midwife in the clinic. Each patient will participate in the study only once and if she has written consent.
Settings and conduct
The study is conducted in Arash Womens Hospital in Baghdarnia St., Tehran, Iran. PCOS diagnosis is based on the Rotterdam criteria. The physician, the researcher midwife and the patient all are aware of received treatment.
Participants/Inclusion and exclusion criteria
Women with polycystic ovarian syndrome and infertility who are candidate for frozen embryo transfer
Inclusion criteria:
1. Age 20-35 years;
2. First or second embryo transfer cycle;
3. Normal uterine cavity
Exclusion criteria:
1. Severe male factor;
2. pregestational diagnosis;
3. Severe endometriosis;
4. Concurrent immune disease;
5.Follicle stimulating hormone level > 10 IU/ml;
6. Body mass index >= 30 Kg/m2
Intervention groups
Patients will randomly selected in two groups to receive either (i) estradiol valerate or (ii) concurrent administration of letrozole and Human Menopausal Gonadotropine (HMG) for ovulation induction
Main outcome variables
Number (ratio) of successful pregnany
Number (ratio) of abortion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090526001952N12
Registration date:2020-03-30, 1399/01/11
Registration timing:retrospective
Last update:2020-03-30, 1399/01/11
Update count:0
Registration date
2020-03-30, 1399/01/11
Registrant information
Name
Ashraf Moini
Name of organization / entity
Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 3283
Email address
hosp_arash@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-23, 1397/07/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
2018-09-23, 1397/07/01
Actual recruitment end date
2019-09-22, 1398/06/31
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Comparison of Hormone replacement therapy with mild ovarian stimulation as endometrial preparation protocols for frozen-thawed embryo transfer in polycystic ovarian syndrome
Public title
Comparison of two endometrial preparation protocols for frozen-thawed embryo transfer in polycystic ovarian syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 20- 35 Years
First or second cycle of embryo transfer
Normal uterine cavity
Exclusion criteria:
Severe male factor
Patients with pregestational diagnosis
Severe endometriosis
Concomitant immunologic disease
Follicle stimulating hormone more than 10 IU
Body mass index equal or more than 30
Age
From 20 years old to 35 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
120
Actual sample size reached:
135
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
In the present study, the gynecologist (fellowship in infertility) and an attending physician (also gynecologist - assistant professor) will be aware of the treatment. Although the patient has been already informed about the study and the treatment arms; however, she will not know about the treatment she received.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tehran University of Medical Sciences
Street address
Baghdarnia St.
City
Tehran
Province
Tehran
Postal code
1653915981
Approval date
2020-01-29, 1398/11/09
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.834
Health conditions studied
1
Description of health condition studied
Polycystic ovarian syndrome
ICD-10 code
E28.2
ICD-10 code description
Polycystic ovarian syndrome
Primary outcomes
1
Description
Number (ratio) of successful pregnancy
Timepoint
40 weeks after study initiation
Method of measurement
Medical examination and ultrasound
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: This group will be received estradiol valerate (Aboureihan Co.). On day 3 after LMP, estradiol valerate is administered at the dose of 4 mg and will be increased after 3 days to 6 mg. The patient will be examined after a week. An endometrial thickness of 8 mm or more is optimum for progesterone administration (Cyclogest, Actoverco), otherwise the dose of estradiol will be increased up to 8 mg. If the optimal endometrial thickness is not achieved after 20 days, embryo transfer will be canceled.
Category
Treatment - Drugs
2
Description
Intervention group 2: Patients will receive letrozole (Femara, Novartis; 2.5 mg, b.i.d.) on day 3 after LMP for 5 days. Afterward treatment with HMG (Karma Co.; 75-150 mg, daily) on day 5 - 9 after LMP. Endometrial thickness, follicle size, and LH serum levels are measured frequently and in case of follicle size of 12-13 mm, an LH measurement will be done on next visit. Transvaginal ultrasound will be performed every 3 days, while hormon therapy is continued. An endometrial thickness of 8 mm or more or a follicle size of 20 mm or more is good for HCG (Ronak Daru; 5000 - 10000 IU) administration for ovulation induction. On day 20th, if endometrial Thickness was less than 7 mm the transfer cycle will be canceled regardless of follicle condition.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr. Azadeh Hosseini
Street address
Baghdarnia St.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
ahosseini11@gmail.com
2
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr. Azadeh Hosseini
Street address
Baghdarnia St.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Email
ahosseini11@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraeian
Street address
Keshavarz Blvd., Qods St.,
City
Tehran
Province
Tehran
Postal code
1417653911
Phone
+98 21 8163 3698
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?