Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization

NCTNCT02865681Other idJZ08-15

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Overview

Status: Completed
Phase: Not applicable
Enrollment: 4 participants (actual)
Sponsor: New Hope Fertility Center · Other
Design: Not randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Jul 2016
Primary completion: 7 Jun 2017
Completion: 7 Jun 2017
First posted: 12 Aug 2016 (estimated)
Last update posted: 19 Mar 2019
Conditions: Infertility

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

201620172018

N/A
Protocol to Minimize Injections and Blood Draws for Women Undergoing in Vitro Fertilization
NCT02865681
1 Jul 2016 to 7 Jun 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of the study is to evaluate the safety and efficacy of nasal gonadotropins (Menopur) in women undergoing IVF. The purpose of this study is also to report and monitor any and all side effects of the nasal Menopur.

Interventions

MenopurDrug
SynarelDrug
HCG triggerDrug
Clomiphene citrateDrug
LetrozoleDrug

Arms2

Active comparator
Conventional IVF
Conventional ovarian stimulation consist of ovarian stimulation with daily gonadotropins injections daily starting in the early follicular phase (cycle day 3). The final maturation of oocytes will be induced with the standard hCG trigger when at least two follicles reached 18 mm or greater. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.
Experimental
IVF protocol using nasal gonadotropins
Instead of injectable gonadotropins, nasal human menopausal gonadotropins (hMG; menopur) and oral clomiphene citrate and/or oral letrozole starting in the early follicular phase (cycle day 3). When at least two follicles reached 18 mm or greater, Synarel (Nafarelin) will be used instead of the injectable HCG trigger. Oocyte retrieval will be performed by either local or general anesthesia depending on the ovarian response, i.e., the number of mature follicles. Retrieved oocytes will be fertilized by IVF/ICSI and subsequently cultured until the blastocyst stage. All blastocysts will be vitrified. A single thawed blastocyst will be transferred in a subsequent natural or artificially prepared cycle.

Primary outcomes2

Outcomes the sponsor listed as primary.

Serum estradiol level
Time frame · 1 year
Registry description
serum estradiol level in pg/mL as representative of ovarian response
Ovarian follicular size
Time frame · 1 year
Registry description
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response

Secondary outcomes(1)

Adverse Events That Are Related to Nasal Menopur Treatment
Time frame · 1 year
Registry description
whether there are any side effects

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

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.

ResultZhang J, Merhi Z. Safety data for the use of nasal human menopausal gonadotropins: a potential novel approach for fertility treatment. JBRA Assist Reprod. 2019 Apr 30;23(2):169-171. doi: 10.5935/1518-0557.20180078. PMID 30500132

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years up to 45 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: 1. Age range: 18-45. The participant should be a woman of reproductive age, i.e., premenopausal who is healthy. 2. Body mass index: 19-35 kg/m2 3. Diagnosis of infertility: inability to conceive with unprotected intercourse after 1 year for women aged \< 35 and after 6 months for women aged \> 35. 4. Pap smear within 1 year should be normal. 5. Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline ultrasound 6. Fallopian tubes will be assessed by hysterosalpingogram in women who have normal ovarian reserve, regular menstrual cycles with a partner who has normal semen analysis. Unless there is a clear diagnosis of a reason for infertility, such as poor sperm, poor ovarian reserve, fallopian tube patency will not be performed because it would not change the treatment. 7. Semen analysis will be performed on every male partner to ensure that there are sperm to be used for IVF/ICSI. 8. All assessment will be performed at baseline and before initiation of any treatment. 9. The investigators will obtain at screening Pap smear, hysteroscopy or saline ultrasound, hysterosalpingography, and semen analysis if they have not been done within one year of baseline. Exclusion Criteria: 1. Any medical condition that interferes with the health of the participant such as uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease. 2. Any type of malignancy. 3. Mental problems that could interfere with the patient's ability to conceive and take care of her baby. 4. Abnormal endometrial cavity that could interfere with implantation and/or carrying the pregnancy.

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