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24. Total gonadotropin dose [ Time Frame: Up to 20 stimulation days ] |
25. Number of stimulation days [ Time Frame: Up to 20 stimulation days ] |
26. Number of dose adjustments [ Time Frame: Up to 20 stimulation days ] |
27. Frequency and intensity of adverse events [ Time Frame: From time of signing informed consent until the end-of-cycle visit in the fresh cycle (up to approximately 6 months) ] |
28. Changes in circulating levels of clinical chemistry compared to baseline [ Time Frame: From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months) ] |
Measured by CHEM-20 |
29. Changes in haematology parameters compared to baseline [ Time Frame: From screening to the end-of-cycle visit in the fresh cycle (approximately 6 months) ] |
Measured by complete blood count (CBC) |
30. Frequency and intensity of injection site reactions (redness, pain, itching, swelling and bruising) assessed by the participant during the stimulation period [ Time Frame: Up to 20 stimulation days ] |
31. Proportion of participants with treatment-induced anti-FSH antibodies [ Time Frame: Up to 28 days after end of the stimulation period ] |
32. Frequency and intensity of immune-related adverse events [ Time Frame: From time of signing informed consent until the end-of-cycle visit in the fresh cycle (approximately 6 months) ] |
33. Proportion of participants with cycle cancellations due to an adverse event, including immune-related adverse events, or due to technical malfunctions of the administration pen [ Time Frame: Up to 20 stimulation days ] |
34. Proportion of participants with ovarian hyperstimulation syndrome (OHSS), overall and by grade, and proportion of participants with moderate/severe OHSS [ Time Frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS) ] |
35. Proportion of participants hospitalized due to ovarian hyperstimulation syndrome (OHSS) and proportion of participants undergoing paracentesis due to OHSS [ Time Frame: ≤9 days after triggering of final follicular maturation (early OHSS), >9 days after triggering of final follicular maturation (late OHSS) ] |
36. Rate of multi-fetal gestation, biochemical pregnancy, spontaneous abortion, ectopic pregnancy (with and without medical/surgical intervention) and vanishing twins in the fresh cycle and in the cryopreserved cycles [ Time Frame: Up to 8-9 weeks after transfer ] |
The percentage of subjects with each of these events will be reported. |
37. Technical malfunctions of the administration pen [ Time Frame: Up to 20 stimulation days ] |
Information from the National Library of Medicine |
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinic... |
Layout table for eligibility information |
Ages Eligible for Study: 18 Years to 34 Years (Adult) |
Sexes Eligible for Study: Female |
Gender Based Eligibility: Yes |
Gender Eligibility Description: Pre-menopausal females between the ages of 18 and 34 years at the time of randomization. |
Accepts Healthy Volunteers: No |
Criteria |
Inclusion Criteria: |
• Informed Consent Documents signed prior to any trial-related procedure. |
• In good physical and mental health in the judgement of the investigator. |
• Pre-menopausal females between the ages of 18 and 34 years. The subjects must be at least 18 years (including the 18th birthday) when they sign the informed consent and no more than 34 years (up to the day before the 35th birthday) at the time of randomization. |
• Body mass index (BMI) between 17.5 and 38.0 kg/m2 (both inclusive) at screening. |
• Infertile women diagnosed with tubal infertility, unexplained infertility, endometriosis stage I/II or with partners diagnosed with male factor infertility, eligible for in vitro fertilization (IVF) and/or intracytoplasmic sperm injection (ICSI) using fresh or frozen ejaculated sperm from male partner or sperm dono... |
• Documented history of infertility for at least 12 months before randomization (not applicable in case of tubal or severe male factor infertility, or when the use of donor sperm is indicated). |
• Regular menstrual cycles of 24-35 days (both inclusive). |
• Hysterosalpingography, hysteroscopy or saline infusion sonography, documenting a uterus consistent with expected normal function (e.g. no evidence of clinically interfering uterine fibroids defined as submucous fibroids of any size or intramural fibroids larger than 3 cm in diameter, no polyps and no congenital str... |
• Transvaginal ultrasound documenting presence and adequate visualization of both ovaries, without evidence of significant abnormality (e.g. enlarged ovaries which would contraindicate the use of gonadotropins) and normal adnexa (e.g. no hydrosalpinx) at screening. Both ovaries must be accessible for oocyte retrieval... |
• Early follicular phase (cycle day 2-4) serum levels of FSH between 1 and 15 IU/L (results obtained within 3 months prior to randomization). |
• Negative serum Hepatitis B Surface Antigen (HBsAg), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV) antibody tests at screening or within 6 months prior to screening. |
• Willing to accept single blastocyst transfer in the fresh cycle and in the cryopreserved cycles initiated within 12 months from the start of COS using blastocysts obtained in this trial. |
Exclusion Criteria: |
• More than one previous COS cycle for IVF/ICSI. |
• Known endometriosis stage III-IV (defined by the revised ASRM classification, 2012 ). |
• Known history of anovulation. |
• One or more follicles greater than or equal to 10 mm (including cysts) observed on the transvaginal ultrasound prior to randomization on stimulation day 1. |
• Known history of recurrent miscarriage (defined as three consecutive losses after ultrasound confirmation of pregnancy [excluding ectopic pregnancy] and before week 24 of pregnancy). |
• Known abnormal karyotype of subject or of her partner / sperm donor, as applicable, depending on source of sperm used for insemination in this trial. In case partner sperm will be used and the sperm production is severely impaired (concentration <1 million/mL), normal karyotype, including no Y-chromosome microdelet... |
• Any known clinically significant systemic disease (e.g. insulin-dependent diabetes). |
• Known inherited or acquired thrombophilia. |
• Active arterial or venous thromboembolism or severe thrombophlebitis, or a history of these events. |
• Any known endocrine or metabolic abnormalities (pituitary, adrenal, pancreas, liver or kidney) with the exception of pharmacologically controlled sub-clinical hypothyroidism. |
• Known tumors of the ovary, breast, uterus, adrenal gland, pituitary or hypothalamus which would contraindicate the use of gonadotropins. |
• Known moderate or severe impairment of renal or hepatic function. |
• Any abnormal finding of clinical chemistry, hematology, thyroid-stimulating hormone (TSH) or prolactin, or vital signs at screening, which is judged clinically significant by the investigator. |
• Known abnormal cervical cytology of clinical significance observed within three years prior to randomization (unless the clinical significance has been resolved). |
• Findings at the gynecological examination at screening which preclude gonadotropin stimulation or are associated with a reduced chance of pregnancy, e.g. congenital uterine abnormalities or retained intrauterine device. |
• Pregnancy (negative urinary pregnancy tests must be documented at screening and prior to randomization) or contraindication to pregnancy. |
• Known current active pelvic inflammatory disease. |
• Use of fertility modifiers during the last menstrual cycle before randomization, including dehydroepiandrosterone (DHEA), metformin or cycle programming with oral contraceptives, progestogen or estrogen preparations. |
Information from the National Library of Medicine |
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. |
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03740737 |
Hide Study Locations |
Locations |
Layout table for location information |
United States, Arizona |
Fertility Treatment Center |
Tempe, Arizona, United States, 85284 |
United States, California |
HRC Fertility |
Encino, California, United States, 91436 |
United States, Connecticut |
Center for Advanced Reproductive Services PC |
Farmington, Connecticut, United States, 06032 |
United States, Delaware |
Reproductive Associates of Delaware |
Newark, Delaware, United States, 19713 |
United States, Florida |
Women's Medical Research Group, LLC |
Clearwater, Florida, United States, 33759 |
Center for Reproductive Medicine |
Winter Park, Florida, United States, 32789 |
United States, Hawaii |
Fertility Institute of Hawaii, INC |
Honolulu, Hawaii, United States, 96814 |
United States, Illinois |
Fertility Centers of Illinois (RH) |
Chicago, Illinois, United States, 60610 |
InVia Fertility |
Hoffman Estates, Illinois, United States, 60169 |
United States, Massachusetts |
Boston IVF |
Waltham, Massachusetts, United States, 02451 |
United States, Minnesota |
Mayo Clinic |
Rochester, Minnesota, United States, 55905 |
United States, North Carolina |
Reproductive Endocrinology Associates of Charlotte (REACH) S. Corporation |
Charlotte, North Carolina, United States, 28207 |
Carolina Conceptions |
Raleigh, North Carolina, United States, 27607 |
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