Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201611001569368 Date of Approval: 07/04/2016
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title induction of ovulation in polycystic ovary syndrome
Official scientific title Drospirenone containing combined oral contraceptive premedication before letrozole ovulation induction in clomiphene resistant PCOS, is it worth the wait?
Brief summary describing the background and objectives of the trial Polycystic ovary syndrome (PCOS) is considered as a common endocrine disorder among women. Chronic anovulation causes infertility in 55%¿75% of patients with PCOS. Clomiphene citrate (CC) is still the standard drug for inducing ovulation. 15%¿20% of patients fail to respond to CC and this is referred to as CC resistance (CCR). Adjunctive therapy options for CC-resistant women include weight loss, insulin-sensitizing agents, bromocriptine, glucocorticoids, extended doses or continued doses of CC, and laparoscopic ovarian drilling. Alternative treatments to CC have been used to induce ovulation in CCR patients, of them aromatase inhibtors (AIs) and gonadotropins are the most commonly used. Exogenous gonadotropin therapy is effective at producing ovulation but is expensive, with significant risks of high-order multiple gestations and ovarian hyperstimulation syndrome. Letrozole is a potent, reversible, and highly selective AI that prevents androgen-to-estrogen conversion. It works by suppressing estrogen production, decreasing the negative feedback of estrogens in the hypothalamus, and subsequently increasing the circulating concentration of follicle stimulating hormone (FSH), and has been used to induce ovulation Letrozole is considered ideal for ovulation induction, as it does not deplete estrogen receptors in central and peripheral target tissues, it has less negative impact on endometrium and cervical mucus, and it typically results in mono-ovulation. Previous studies showed that the use of OCP for 2 months followed by the CC produced effective ovulation and pregnancy rates in patients who had not ovulated with maximum doses of CC alone. It was suggested that this approach might offer a low-cost and low-risk alternative to gonadotropin therapy for these patients. This study is designed to evaluate the effectiveness of 2 months drospirenone-ethinyl estradiol OCP pretreatment for CCR cases followed by letrozole induction of ovulation.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Obstetrics and Gynecology,Polycystic ovary syndrome
Sub-Disease(s) or condition(s) being studied Fertility-male
Purpose of the trial Treatment: Other
Anticipated trial start date 01/05/2016
Actual trial start date 07/11/2016
Anticipated date of last follow up 30/12/2016
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
Actual target sample size (number of participants)
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
Parallel: different groups receive different interventions at same time during study Randomised Simple randomisation using a radomisation table created by a computer software program Sealed opaque envelopes Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group drospirenone-ethinyl estradiol OCP pretreatment ethinylestradiol (EE) 30 mcg+drospirenone 3 mg 42 days Pretratment. 2.5mg letrozole twice daily for 5 days from 2nd day of cycle. Human chorionic gonadotropin once a folllicle measures 18mm 50
Control Group Letrozole 2.5 mg twice daily 5 days starting from the 2nd day of the cycle induction of ovulation. Human chorionic gonadotropin once one follicle measures 18mm 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
clomiphene resistant anovulatory polycystic ovary patients, normal hysterosalpingogram or laparoscopy; no recorded history of pelvic surgery and/or pelvic inflammatory disease, normal male semen analysis Presence of any infertility factors other than anovulatory PCOS, such as hyperprolactinemia, hypothalamic amenorrhea, premature ovarian failure, tubal or male factor infertility. 18 Year(s) 40 Year(s) Female
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 15/03/2016 Menoufia Faculty of Medicine Medical Ethics Committee for Human Research
Ethics Committee Address
Street address City Postal code Country
Yassin Abdelghaffar shibin el kom - menoufia 32511 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Ovulation Midluteal
Secondary Outcome the mean number of follicles 14 mm or more at the time of hCG administration
Secondary Outcome Pregnancy rate 14 days after HCG adminstration
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Menoufia university - Faculty of medicine - Obstetrics and Gynecology department Yassin abdel Ghaffar Shibin el Kom - Menoufia 32511 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Menoufia University - Faculty of mdicine Yassin abdel Ghaffar Shibin el Kom - Menoufia 32511 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Menoufia University - Faculty of mdicine Yassin abdel Ghaffar Shibin el Kom - Menoufia 32511 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Haitham Aboali Hamza Al Fath st. Berket el sabaa 32651 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Hamza haithamaboali80@gmail.com +201001359136 Al Fath st.
City Postal code Country Position/Affiliation
Berket El SAbaa - Menoufia 32651 Egypt Lecturer of obstetrics and gynecology/ Faculty of medicine - Menoufia university
Role Name Email Phone Street address
Public Enquiries HAITHAM HAMZA haithamaboali80@gmail.com +201001359136 Al Fath st.
City Postal code Country Position/Affiliation
Berket El SAbaa - Menoufia 32651 Egypt Lecturer of Obstetrics and Gynecology - Faculty of Medicine - Menoufia university
Role Name Email Phone Street address
Scientific Enquiries HAITHAM HAMZA haithamaboali80@gmail.com 01001359136 Al Fath st.
City Postal code Country Position/Affiliation
Berket El Sabaa - Menoufia 32651 Egypt Lecturer of Obstetrics and Gynecology - Faculty of Medicine - Menoufia university
REPORTING
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