Primary and secondary infertility
Conditions
Interventions
None listed
Sponsors
Kamiya Ladies Clinic
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Written informed consent is obtained from the patients who are enrolled. 2.Age younger than 41 years, willing to undergo assisted reproductive treatment at our clinic 3.Anti-Mullerian hormone (AMH) levels greater than 1.0 ng/ml 4. First or second time of IVF/intra-cytoplasmic sperm injection (ICSI) at our clinic 5.Regular menstrual cycles of 24-35 days (both inclusive), presumed to be ovulatory. 6.In good physical and mental health in the judgement of the investigator. 7.Body mass index (BMI) between 17.5 and 32.0 kg/m2 (both inclusive) at screening.
Exclusion criteria
Exclusion criteria: Known endometriosis stage III-IV (defined by the revised ASRM classification, 1996). One or more follicles >10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1 (puncture of cysts is allowed prior to randomization) Patients with untreated hydrosalpinx Patients with untreated intrauterine lesions (endometrial polyps or submucosal myoma) Patients with serious primary disease Patients with uncontrolled diabetes or other endocrine complications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of good embryos available for embryo transfer | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Proportion of Subjects With Extreme Ovarian Responses Extreme ovarian response defined as <2, >25 oocytes retrieved. Subjects with cycle cancellation due to poor ovarian response are included as <1 oocytes retrieved. 2.Number of growing Follicles At oocyte retrieval 3. Number of picked up Follicles At oocyte retrieval 4. Percentage of Metaphase2 (M2) Oocytes 5.Fertilization Rate,The fertilization rate was defined as the number of oocytes with 2 pronuclei divided by the number of oocytes retrieved. 6.Number of premature Luteinizing Hormone (LH) surge occurrences 7.Proportion of Subjects With Early Ovarian hyper stimulation syndrome (OHSS) (Including OHSS of Moderate/Severe Grade) and/or Preventive Interventions for Early OHSS (Time Frame: Up to 9 days after triggering of final follicular maturation ) Early OHSS is defined as OHSS with onset <9 days after triggering of final follicular maturation. Classification of grade is according to Golan's classification system, and all OHSS cases are graded as mild, moderate or severe. 8.Circulating Concentrations of Estradiol, Progesterone, LH,FSH 9. Number of Stimulation Days 10.Number of Subjects With Adverse Events 11.Positive Beta Unit of Human Chorionic Gonadotropin (hCG) Rate Defined as positive hCG test 13-15 days after embryo transfer. 12.Clinical Pregnancy Rate,Defined as at least one gestational sac 5-6 weeks after transfer. 13.Ongoing Pregnancy Rate,Defined as at least one intrauterine viable fetus 10-11 weeks after transfer. 14.Proportion of Subjects With Early Pregnancy Losses Grouped according to occurrence of biochemical pregnancy, spontaneous abortion, vanishing twin or ectopic pregnancy (with and without medical/surgical intervention). Frequency of early pregnancy losses are presented. | — |
Countries
Japan
Contacts
Public ContactNanako Iwami
Kamiya Ladies Clinic Reproductive health
Outcome results
None listed