Infertility, Insemination, Artificial, Ovulation Induction
Conditions
Brief summary
The goal of this retrospective observational study is to compare two types of follicle-stimulating hormone, follitropin delta and follitropin alfa, used for ovarian stimulation in Indonesian women undergoing intrauterine insemination (IUI) for infertility treatment. The study includes women younger than 40 years who underwent IUI at Halim Fertility Center, Indonesia, between January 2020 and December 2022. The main questions this study aims to answer are: * Is ovarian stimulation with a simplified follitropin delta dosing regimen associated with a different clinical pregnancy rate compared with conventional follitropin alfa treatment? * Are the rates of multiple pregnancy and ovarian hyperstimulation syndrome (OHSS) different between the two treatment groups? Researchers will compare women who received follitropin delta with women who received follitropin alfa as part of their fertility treatment. The study hypothesis is that a simplified follitropin delta regimen may provide comparable fertility outcomes while maintaining an acceptable safety profile compared with conventional follitropin alfa treatment. Participants had already received one of the two ovarian stimulation treatments as part of their routine clinical care. Researchers will review their medical records and compare treatment characteristics and IUI outcomes between the two groups. The study does not assign participants to treatment because the treatments were given before the study data were analyzed.
Interventions
Follitropin delta was administered once daily beginning on cycle day 2 or 3 at an initial dose of 5 μg/day using a simplified dose-equivalent regimen. The dose could be adjusted according to ovarian response assessed by ultrasound monitoring. Stimulation was continued until the leading follicle reached ≥17 mm in diameter, followed by final oocyte maturation triggering and intrauterine insemination approximately 36 hours later.
Follitropin alfa was administered once daily beginning on cycle day 2 or 3 at an initial dose of 75 IU/day. The dose could be adjusted according to ovarian response assessed by ultrasound monitoring. Stimulation was continued until the leading follicle reached ≥17 mm in diameter, followed by final oocyte maturation triggering and intrauterine insemination approximately 36 hours later.
Sponsors
Stella Maris Women and Children Hospital
Halim Fertility Center
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Inclusion criteria
* Female age \<40 years * Undergoing intrauterine insemination (IUI) for infertility treatment * Bilateral tubal patency * Unexplained infertility, anovulation, and/or mild male-factor infertility * For mild male-factor infertility: total motile sperm count (TMSC) 10-20×10\^6/mL * Baseline serum FSH \<10 mIU/mL
Exclusion criteria
* Pre-existing medical conditions considered unsuitable for IUI treatment * Endometriotic cyst * Adenomyosis * Congenital uterine anomalies * Spontaneous ovulation * Poor ovarian response
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinical Pregnancy Rate | During early pregnancy follow-up 4-6 weeks after IUI | The proportion of IUI cycles resulting in a clinical pregnancy. Clinical pregnancy was defined as ultrasonographic visualization of one or more gestational sacs or other definitive clinical evidence of pregnancy. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Multiple Pregnancy Rate | During early pregnancy follow-up 4-6 weeks after IUI | The proportion of IUI cycles resulting in a multiple clinical pregnancy, defined as the presence of more than one gestational sac identified by ultrasonography. |
| Ovarian Hyperstimulation Syndrome Rate | 2-4 weeks after IUI | The proportion of IUI cycles in which ovarian hyperstimulation syndrome (OHSS) occurred following controlled ovarian stimulation. |
Countries
Indonesia
Outcome results
None listed