A Phase 4 interventional study of Letrozol (Femara, Novartis) and Letrozol (Femara, Novartis) combined with Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) in Infertility, Female, sponsored by Menoufia University. Status unknown. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.
Sponsored by Menoufia University · Phase 4, Interventional, and Treatment
The aim of this study will be to compare between 4 different induction protocols in women who:
All induction protocols will be carried out in non-IVF cycles, and continued for 3 cycles or until pregnancy whichever will be earlier.
The study will include 4 treatment groups:
GROUP 1: Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days.
GROUP 2: Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test GROUP 3: Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry.
GROUP 4: Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test For follow up:US folliculometry will be done on Day 8 in all groups. Further appointments for folliculometry will be given upon the response. Dominant follicle will be diagnosed on Day 8 if the average follicular diameter is 12mm or more (taken in 2 perpendicular diameters) then follow up will be continued till the diameter reaching 18-22mm so that triggering ovulation will be carried out by administration of human chorionic gonadotrophins (Epifasi 5000 IU, ampoule, EIPICO pharmaceuticals, Egypt). All women will be advised to receive the injection within 12 hours of the last follicular measurement. Women will be advised to have unprotected intercourse 24-36h following hCG injection. Serum β-hCG will be measured after 2 weeks to check for pregnancy and US will be performed after 2-4 weeks from B-hCG results to confirm the presence of pregnancy.
Each couple will be involved in the study for 3 treatment cycles if pregnancy will not occur but still having the option not to continue in our study where we will manage them outside the study protocol.
Women who will get pregnant will be followed for 12w gestational age for possible detection of 1st trimester abortion.
2,506 studies on the registry are indexed under Infertility; 407 are open to participants now.
This study's planned enrollment of 176 is above the median of 120 across 1,698 interventional studies indexed under Infertility.
Browse Infertility studies →Menoufia University is the lead sponsor of 192 studies on the registry; 53 are open to participants now.
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Exclusion Criteria:
GROUP 1: Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days.
Drug: Letrozol (Femara, Novartis)
GROUP 2: Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test
Drug: Letrozol (Femara, Novartis) combined with Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt)
Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry.
Drug: highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland)
Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test
Drug: highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland) combined with metformin
Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days.
Participants of this group will receive Letrozol (Femara, Novartis) at a dose of 2.5mg twice daily starting from day 3 of the cycle for 5 days. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test
Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry.
Participants of this group will receive highly purified lyophilized Uroffollitropin (Fostimon, IBSA Institut Biochimique SA, Lugano, Switzerland.) at a dose of 75IU S.C or IM starting from day 3 of the cycle for 5 days. Readjustment of the dose will occur upon the results of day 8 folliculometry. Metformin (Cidophage 500 mg, Cid Pharmaceuticals, Egypt) 500 mg twice daily will also started from day 3 till the date of doing pregnancy test
Occurrence of ovulation
US detection of one or more follicles of 18mm or more
Time frame: 18 month
Number of dominant follicles
US detection of follicles \>18mm
Time frame: 18 month
Endometrial thickness
US assessment of endometrial thickness
Time frame: 18 months
Occurrence of pregnancy which will be subdivided into: chemical pregnancy or clinical pregnancy
type of pregnancy
Time frame: 18 months
Total number of patients getting pregnant after each treatment cycle in each group
record occurrence of pregnancy
Time frame: 18 months
Number of cycles cancelled in each group
detect cycle cancellation
Time frame: 18 months
Number of patients developing OHSS in each group
detect ovarian hyperstimulation syndrom
Time frame: 18 months
Number of patients having multiple pregnancy in each group
detect multiple pregnancy
Time frame: 18 months
Number of patients ended by 1st trimester miscarriage in each group
detect miscarriage
Time frame: 18 months
Side effects recorded in each group
record side effects that patients complaint
Time frame: 18 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.
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