Primary outcomeMean· 2 days
Total Fertilization Proportion (i.e. Total Competent Proportion)
| Group | Value (ratio) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 0.59 | 0.029 |
| Standard Dose of hCG Alone | 0.65 | 0.024 |
Trial · Interventional
CompletedPhase 3Results postedRegistry dataAdministration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
NCTNCT02310919 (opens ClinicalTrials.gov in a new tab)Other idP0503461
This trial does not test a peptide that PepBank tracks.
- Measures hCG (human chorionic gonadotropin), does not give it. It appears in an outcome measure.
Overview
- Status
- Completed
- Phase
- Phase 3
- Enrollment
- 105 participants (actual)
- Sponsor
- University of California, San Francisco · Other
- Design
- Randomized · Double masking
- Countries
1 country
United States
- Start
- Sept 2014
- Primary completion
- 20 Jun 2018
- Completion
- 20 Jun 2018
- First posted
- 8 Dec 2014 (estimated)
- Last update posted
- 29 Apr 2022
- Conditions
- Infertility
Timeline
1 trial · 1 completed · 1 with posted results
- Completed
- Ongoing
- Not yet recruiting
- Stopped
- Estimated dates (est.)
- Results posted
201420152016201720182019
- Ph 3
Administration of Follicle-stimulating Hormone (FSH) and Low Dose Human Chorionic Gonadotropin (hCG) for Oocyte Maturity While Decreasing hCG Exposure in In Vitro Fertilization (IVF) Cycles
NCT02310919Sept 2014 to 20 Jun 2018
Registry summary
Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.
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).
Interventions
- Low dose hCG plus FSH co-triggerDrug
- Standard dose of hCGDrug
Arms2
Experimental
Low dose hCG plus FSH co-trigger
On the day of ovulation trigger the patient will receive hCG 1,500 IU SQ plus FSH 450 IU SQ
Active comparator
Standard dose of hCG alone
On the day of ovulation trigger the patient will receive standard dose of hCG (10,000 or 5,000 IU SQ)
Primary outcomes1
Outcomes the sponsor listed as primary.
Total Fertilization Proportion (i.e. Total Competent Proportion)
Time frame · 2 days
Registry description
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.
Secondary outcomes(20)
Number of Oocytes Retrieved
Time frame · 1 day
Registry description
The total number of oocytes recovered at the oocyte retrieval.
Number of MII Oocytes
Time frame · 1 day
Registry description
The number of metaphase 2 oocytes (MII) recovered which can only be calculated in patients that underwent intracytoplasmic sperm injection.
Total Oocyte Maturity Rate
Time frame · 1 day
Registry description
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).
Mature Oocyte Recovery Proportion
Time frame · 1 day
Registry description
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.
ICSI Fertilization Rate
Time frame · 2 days
Registry description
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.
High Quality Cleavage-stage Embryos
Time frame · 4 days
Registry description
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.
High Quality Blastocyst Embryos
Time frame · 6 days
Registry description
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.
Livebirth Rate From All Fresh Transfers
Time frame · 10 months
Registry description
Livebirth rate (LBR) was defined as a liveborn at the time of the analysis. Pregnancy outcomes were calculated for all fresh transfers.
Bloating Score
Time frame · 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
Registry description
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 1. \- Mild bloating. Able to continue daily activities without discomfort. 2. \- Mild to moderate bloating. Able to continue daily activities but with mild discomfort. 3. \- Moderate bloating. Able to continue daily activities but with moderate discomfort. 4. \- Moderate to severe bloating. Difficulty performing daily activities. 5. \- Severe bloating. Abdomen feels very tense and unable to perform daily activities.
Abdominal Circumference
Time frame · 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
Registry description
Change in abdominal circumference (in centimeters) from day of baseline ultrasound to post-trigger day 5.
Body Weight
Time frame · 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
Registry description
Change in body weight from day of baseline ultrasound to post-trigger day 5.
Serum hCG T+1
Time frame · 1 day
Registry description
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of human chorionic gonadotropin (hCG).
Serum FSH T+1
Time frame · 1 day
Registry description
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of follicle stimulating hormone (FSH).
Serum P4 on T+1
Time frame · 1 day
Registry description
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of Progesterone (P4).
Serum E2 on T+1
Time frame · 1 day
Registry description
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of estradiol (E2).
Serum LH on T+1
Time frame · 1 day
Registry description
Blood samples were collected about 12 hours after trigger (T+1) to assess the serum concentration of luteinizing hormone (LH).
Serum hCG on T+2
Time frame · 2 days
Registry description
Blood samples were collected about 2 days after trigger (T+2) to assess the serum concentration of human chorionic gonadotropin (hCG).
Serum FSH on T+2
Time frame · 2 days
Registry description
Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of follicle stimulating hormone (FSH).
Serum P4 on T+2
Time frame · 2 days
Registry description
Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of progesterone (P4).
Serum E2 on T+2
Time frame · 2 days
Registry description
Blood samples were collected 2 days after trigger (T+2) to assess the serum concentration of estradiol (E2).
Posted results
Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.
Primary outcome results
Secondary and other outcome results(7)
Secondary outcomeMean· 1 day
Number of Oocytes Retrieved
| Group | Value (oocytes) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 13.6 | 0.84 |
| Standard Dose of hCG Alone | 16.1 | 1.01 |
Secondary outcomeMean· 1 day
Number of MII Oocytes
| Group | Value (MII oocytes) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 10.8 | 0.74 |
| Standard Dose of hCG Alone | 12.5 | 0.81 |
Secondary outcomeMean· 1 day
Total Oocyte Maturity Rate
| Group | Value (ratio of MII oocytes) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 0.75 | 0.021 |
| Standard Dose of hCG Alone | 0.77 | 0.020 |
Secondary outcomeMean· 1 day
Mature Oocyte Recovery Proportion
| Group | Value (ratio) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 0.81 | 0.032 |
| Standard Dose of hCG Alone | 0.92 | 0.018 |
Secondary outcomeMean· 2 days
ICSI Fertilization Rate
| Group | Value (ratio of fertilized oocytes) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 0.80 | 0.032 |
| Standard Dose of hCG Alone | 0.80 | 0.024 |
Secondary outcomeMean· 4 days
High Quality Cleavage-stage Embryos
| Group | Value (ratio of good quality embryos) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 0.59 | 0.043 |
| Standard Dose of hCG Alone | 0.62 | 0.027 |
Secondary outcomeMean· 6 days
High Quality Blastocyst Embryos
| Group | Value (ratio of good quality embryos) | Spread |
|---|---|---|
| Low Dose hCG Plus FSH Co-trigger | 0.67 | 0.044 |
| Standard Dose of hCG Alone | 0.68 | 0.035 |
Adverse events, as posted
| Group | Deaths | Serious events | Other events |
|---|---|---|---|
| Low Dose hCG Plus FSH Co-triggerOn the day of ovulation trigger the patient will receive Low dose hCG 1,500 IU subcutaneously plus FSH 450 IU co-trigger subcutaneously | 0 / 54 | 0 / 54 | 0 / 54 |
| Standard Dose of hCG AloneOn the day of ovulation trigger the patient will receive standard dose of hCG 10,000 or 5,000 IU subcutaneously. | 0 / 51 | 1 / 51 | 1 / 51 |
Each cell reads participants affected / participants at risk, as the registry posted them.
Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works
Studies0
Studies that cite this trial.
No study cites this trial.
Other registry references
References listed at the registry that are not in PepBank. They link to PubMed.
- DerivedAnaya Y, Cakmak H, Mata DA, Letourneau J, Zhang L, Lenhart N, Juarez-Hernandez F, Jalalian L, Cedars MI, Rosen M. Triggering with 1,500 IU of human chorionic gonadotropin plus follicle-stimulating hormone compared to a standard human chorionic gonadotropin trigger dose for oocyte competence in in vitro fertilization cycles: a randomized, double-blinded, controlled noninferiority trial. Fertil Steril. 2022 Aug;118(2):266-278. doi: 10.1016/j.fertnstert.2022.05.006. Epub 2022 Jun 12. PMID 35705380
Eligibility
Who could join, as posted.
- Sex
- Female
- Age
- from 18 Years up to 41 Years
- Healthy volunteers
- Accepted
Inclusion and exclusion criteria, as posted
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
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