Clinical trial · Interventional
Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Female Infertility
Comparative Study on the Efficacy of Ovarian Stimulation Protocols on the Success Rate of ICSI in Women With Infertility Problems
NCT04071574CI-TRIAL-00066235CS-EOSP-ICSIcompletedPhase 1 / Phase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The study will describe the effectiveness of ovarian stimulation in correlation with female infertility causes in a Lebanese population: a comparative study using 5 protocols of ovulation induction (treatment with "A" gonadotropins alone, "B" short GnRH agonist, "C" multiple-dose GnRH antagonist, "D" long GnRH agonist and "E" combined protocol of GnRH antagonist and agonist) and the outcomes of ICSI. This comparative study will help clinicians to select the relevant protocol of ovarian stimulation related to the female infertility disorders.
Conditions
Conditions (17)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Congenital Uterine Anomaly | — | UNRESOLVED | — |
| Ectopic Pregnancy | — | UNRESOLVED | — |
| Endometriosis | — | UNRESOLVED | — |
| Female Infertility | — | UNRESOLVED | — |
| Female Infertility - Cervical/Vaginal | — | UNRESOLVED | — |
| Female Infertility Due to Ovulatory Disorder | — | UNRESOLVED | — |
| Female Infertility Due to Tubal Block | — | UNRESOLVED | — |
| Female Infertility Due to Tubal Occlusion | — | UNRESOLVED | — |
| Female Infertility Endocrine | — |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| GnRH antagonist | Drug | — | UNRESOLVED |
| GNRH-A Triptorelin | Drug | — | UNRESOLVED |
| Gonadotropins | Drug | — | UNRESOLVED |
| Human Chorionic Gonadotropin (hCG) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (5)
- type
- ACTIVE_COMPARATOR
- label
- Protocol "A"
- description
- Protocol with gonadotropins alone without agonist or antagonist: Gonadotropin treatment begins after spontaneous menses. The gonadotropins (e.g. Menopur, 150-225IU) are injected daily from D2/3 of the cycle (Gonadotropin dose varies based on the follicular response). The moment to trigger ovulation by administration of HCG (e.g. Ovitrelle or Pregnyl, 10.000IU) is determined by monitoring ovulation (folliculogenesis) approximately 14 days after gonadotropins regimen and the presence of at least 3 follicles with 18 mm sizes and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.
- interventionNames
- Drug: Human Chorionic Gonadotropin (hCG)
- Drug: Gonadotropins
- type
- ACTIVE_COMPARATOR
- label
- Protocol "B"
- description
- Short GnRH agonist protocol: For the short GnRH agonist protocol, the administration of gonadotropins begins at the same time as that of the agonist, which makes it possible to take advantage of the action of endogenous gonadotropins released by the flare-up effect of the agonist. A low dose of GnRH agonist (e.g., triptorelin (Decapeptyl 0.1mg/day)) is administered in parallel to gonadotropin (e.g. Menopur, 150-225 IU) daily starting on cycle-day 2 (Gonadotropin dose varies based on the follicular development). Continual administration of GnRH agonist and gonadotropin lasts until HCG triggering (e.g. Ovitrelle or Pregnyl, 10.000IU), \~14 days post GnRH agonist regimen when follicles size reached 16-18 mm and at least the levels of E2 reaches 250-300 pg/ml. 36 h after HCG triggering, the mature oocytes are retrieved.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
- Maximum age
- 44 Years
Show eligibility criteria text
Inclusion Criteria: * must not show any of the excluded criteria * Patients affected by female infertility due to particularly Ovulatory Disorder, Premature Ovarian Failure, Polycystic Ovary Syndrome, Tubal Origin, Ectopic Pregnancy, Salpingitis, Tubal Block/Occlusion, Hydrosalpinx, Cervical/Vaginal, Endocrine, Endometriosis, Fibroids, Congenital Uterine Anomaly, Infections Uterine, and Female Infertility of Other Origin * The selection of subjects' age must be group matched between protocols of treatment. Premature ovarian failure is defined as AMH (Anti Mullerian Hormone) ≤ 2 ng/mL. * Willing to collaborate and to attend to the clinical follow-ups for the next three years * Patients willing to sign informed consent * Able and willing to comply with all study requirements * Absence of genetic causes * Medically suitable to undergo ovarian stimulation * Normal serum chemistry and hematology screening tests * Negative human immunodeficiency virus (HIV), hepatitis B (HBV), hepatitis C (HCV) serology * No history of malignancy * Complete history \& physical examination Exclusion Criteria: * Subjects to be excluded from the study if the male (husband) had any male infertility problem(s) * Patients with any genetic abnormalities * Patients with histories of neurologic conditions including moderate or severe head injury, stroke, cerebral or bone damage or malignancies, brain abnormalities, learning disability, major medical or psychiatric illness, and metabolic/cardiovascular disease or evidence of cardiac/renal damage or malignancies, alcohol, loss of weight during the last 2 years, chemotherapy or immunosuppressive therapy. * Women aged 45 years and older, under 21 years
References
Publications (0)
Data not yet available
No reference posted for this study.