Infertility Clinical Trial
Official title:
Concomitant Administration of FSH With a Low Dose of hCG (1,500 IU) Has Equivalent Oocyte Developmental Competence While Decreasing the Exposure to hCG in IVF Cycles: A Double Blind Randomized Control Trial
Verified date | April 2022 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This is a randomized, double-blind, single center clinical trial study to compare oocyte competence and risk of ovarian hyperstimulation syndrome (OHSS) after receiving the standard dose of human chorionic gonadotropin (hCG) ovulation trigger or a lower dose of hCG plus concomitant follicle stimulating hormone (FSH) co-trigger in women undergoing in vitro fertilization (IVF).
Status | Completed |
Enrollment | 105 |
Est. completion date | June 20, 2018 |
Est. primary completion date | June 20, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 41 Years |
Eligibility | Inclusion Criteria: The target population includes couples undergoing IVF. All eligible couples will be asked to join the study. Study participants will be recruited from the Reproductive Endocrinology Clinic at University of California at San Francisco Center for Reproductive Health. Patients receiving any type of stimulation protocol for IVF will be offered participation in the study. Exclusion Criteria: - Age >41 years old - Antral Follicle Count (AFC; 2-10 mm) < 8 - Body Mass Index > 30 kg/m2 - History of = 2 prior canceled IVF cycles secondary to poor response - Diagnosis of cancer - Any significant concurrent disease, illness, or psychiatric disorder that would compromise patient safety or compliance, interfere with consent, study participation, follow-up, or interpretation of study results - Undergoing embryo co-culture - Use of any of the following medications: Growth Hormone, Sildenafil, or Aspirin (except if being used for hypercoagulable state) - Severe male factor infertility diagnosis. Male factor infertility diagnosis should be cleared for eligibility by the PI based on previous patient history of fertilization outcomes and/or expected fertilization outcomes of the cause of male factor infertility based on known scientific data. - Ovulation trigger less than or greater than 36 hours to oocyte retrieval - Serum estradiol level >5,000 pg/ml on the day of expected trigger due to high risk of OHSS |
Country | Name | City | State |
---|---|---|---|
United States | University of California at San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Ferring Pharmaceuticals |
United States,
Bianchi V, Dal Prato L, Maccolini A, Mazzone S, Borini A. Inadvertent recombinant human follicle stimulating hormone bolus instead of human chorionic gonadotrophin leads to the retrieval of competent oocytes in IVF program. Fertil Steril. 2009 Nov;92(5):1747.e1-3. doi: 10.1016/j.fertnstert.2009.07.998. Epub 2009 Sep 3. — View Citation
Chen X, Chen SL, He YX, Ye DS. Minimum dose of hCG to trigger final oocyte maturation and prevent OHSS in a long GnRHa protocol. J Huazhong Univ Sci Technolog Med Sci. 2013 Feb;33(1):133-136. doi: 10.1007/s11596-013-1085-z. Epub 2013 Feb 8. — View Citation
Egbase PE, Sharhan MA, Masangcay M, Egbase E. Follicle stimulating hormone (FSH) administer with trigger dose human chorionic gonadotropin (hCG) completely prevents ovarian hyperstimulation (OHSS): Randomised controlled study. [Abstract] Fertil Steril 2011; 96(3): S20.
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* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Total Fertilization Proportion (i.e. Total Competent Proportion) | The number of fertilized oocytes (2-pronuclei) after standard in vitro fertilization or intra-cytoplasmic sperm injection divided by the total number of oocytes retrieved as a measure of oocyte competence. | 2 days | |
Secondary | Number of Oocytes Retrieved | The total number of oocytes recovered at the oocyte retrieval. | 1 day | |
Secondary | Number of MII Oocytes | The number of metaphase 2 oocytes (MII) recovered which can only be calculated in patients that underwent intracytoplasmic sperm injection. | 1 day | |
Secondary | Total Oocyte Maturity Rate | Oocyte maturity rate was determined by the number of meta phase 2 (MII) oocytes divided by the number of oocytes retrieved. This outcome was only assessed in patients undergoing intracytoplasmic sperm injection (ICSI). | 1 day | |
Secondary | Mature Oocyte Recovery Proportion | Mature oocyte recovery proportion is defined as the number of MIIs divided by the total number of follicles greater or equal to 13mm in size on trigger day. | 1 day | |
Secondary | ICSI Fertilization Rate | ICSI fertilization rate was determined by the number of 2 pro-nuclei (2PN) divided by the number of MII oocytes. This was only assessed in patients undergoing ICSI. | 2 days | |
Secondary | High Quality Cleavage-stage Embryos | Good quality embryo development was compared between trigger groups by calculating the ratio of good quality embryos to the total number of cleavage-stage embryos. A good quality cleavage-stage embryo was defined by having a cell number of 7 to 10 and <10% of cell fragmentation based on a modified Veeck's grading system. | 4 days | |
Secondary | High Quality Blastocyst Embryos | A high quality blastocyst was defined as grade 3 or higher expansion plus inner cell mass and trophectoderm grading of A or B based on Gardner's criteria. The number describes the degree of embryo expansion on a scale from 1-6. As the embryo expands, the degree of expansion increases. The first letter indicates on a scale from A to C (A being the highest) the quality of the inner cell mass. The second letter is also on a scale from A to C (A being the highest) and indicates the quality of the trophectoderm. | 6 days | |
Secondary | Livebirth Rate From All Fresh Transfers | Livebirth rate (LBR) was defined as a liveborn at the time of the analysis. Pregnancy outcomes were calculated for all fresh transfers. | 10 months | |
Secondary | Bloating Score | Change in bloating scores from day of baseline ultrasound to post-trigger day 5. The patient's clinical symptoms will be evaluated based on a bloating score reported by each patient on the day of ovulation trigger and then 5 days after the oocyte retrieval will be determined. The bloating score will range on a scale from 0-5. The number describes the degree of bloating and will increase as the degree of bloating increases. The bloating score will be determined as follows: 0 - No bloating - Mild bloating. Able to continue daily activities without discomfort. - Mild to moderate bloating. Able to continue daily activities but with mild discomfort. - Moderate bloating. Able to continue daily activities but with moderate discomfort. - Moderate to severe bloating. Difficulty performing daily activities. - Severe bloating. Abdomen feels very tense and unable to perform daily activities. |
about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | |
Secondary | Abdominal Circumference | Change in abdominal circumference (in centimeters) from day of baseline ultrasound to post-trigger day 5. | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | |
Secondary | Body Weight | Change in body weight from day of baseline ultrasound to post-trigger day 5. | about 16 days (varies by subject), accounts for the median length of IVF stimulation in this study being 11 days from baseline to 5 days post trigger | |
Secondary | Serum hCG T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of human chorionic gonadotropin (hCG). | 1 day | |
Secondary | Serum FSH T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of follicle stimulating hormone (FSH). | 1 day | |
Secondary | Serum P4 on T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of Progesterone (P4). | 1 day | |
Secondary | Serum E2 on T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of estradiol (E2). | 1 day | |
Secondary | Serum LH on T+1 | Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of luteinizing hormone (LH). | 1 day | |
Secondary | Serum hCG on T+2 | Blood samples were collected about 2 days after trigger (T+2) to assess the serum concentration of human chorionic gonadotropin (hCG). | 2 days | |
Secondary | Serum FSH on T+2 | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of follicle stimulating hormone (FSH). | 2 days | |
Secondary | Serum P4 on T+2 | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of progesterone (P4). | 2 days | |
Secondary | Serum E2 on T+2 | Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of estradiol (E2). | 2 days | |
Secondary | Serum HCG on T+5 | Blood samples were collected 5 days after trigger (T+5) to assess the serum concentration of human chorionic gonadotropin (hCG). | 5 days | |
Secondary | Serum FSH on T+5 | Blood samples were collected 5 days after trigger (T+5) to assess the serum concentration of follicle stimulating hormone (FSH). | 5 days | |
Secondary | Serum LH on T+5 | Blood samples were collected about 5 days after trigger (T+5) to assess the serum concentration of luteinizing hormone (LH). | 5 days | |
Secondary | Follicular hCG | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of human chorionic gonadotropin (hCG). | 2 days | |
Secondary | Follicular FSH | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of follicle stimulating hormone (FSH). | 2 days | |
Secondary | Follicular P4 | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of progesterone (P4). | 2 days | |
Secondary | Follicular E2 | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of estradiol (E2). | 2 days | |
Secondary | Follicular VEGF | Follicular fluid was individually aspirated at oocyte retrieval from the lead follicle in each ovary using a single lumen needle. The mean concentration between right and left follicles collected was compared to assess the follicular concentration of vascular endothelial growth factor (VEGF). | 2 days |
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