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

Sponsor

New Hope Fertility Center (Other)

Overall Status

Completed

CT.gov ID

NCT02865681

Collaborator

(none)

Enrollment

Location

Arms

11.2

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Infertility	Drug: Menopur Drug: Synarel Drug: HCG trigger Drug: Clomiphene citrate Drug: Letrozole	N/A

Detailed Description

Gonadotropins are used during fertility treatments such as intrauterine insemination (IUI) or in vitro fertilization (IVF). These fertility medications are given by injection that contain follicle-stimulating hormone (FSH) alone or combined with luteinizing hormone (LH). During a regularly occurring menstrual cycle, both FSH and LH are produced by the pituitary gland in the brain to naturally stimulate the ovaries to make a single egg each month. When FSH and/or LH are given as an injection as fertility treatment, they work directly on the ovaries to make multiple follicles which are cysts containing the eggs.

Injections of gonadotropins are started early (usually on the third day) in the menstrual cycle to cause multiple eggs to grow to a mature size. Close monitoring of patients with ultrasound and blood are usually needed for monitoring. The ultrasound measures the size of the ovarian follicles. Blood is usually drawn every other day or daily (for a total of 12 days on average) for measurement of Estradiol (E2), progesterone (P4), and luteinizing hormone (LH). The measurement of E2, P4 and LH is intended to quantify the response of the ovaries to the daily injectable gonadotropins. When the follicles grow to a large size (usually 18 mm), human chorionic gonadotropin (hCG), another injectable medication, is then used to trigger the maturity of the eggs before performing egg retrieval during an IVF cycle.

Instead of injectable gonadotropins, this study uses nasal gonadotropins (Menopur) in order to evaluate its safety and efficacy of in women undergoing IVF.

Study Design

Study Type:

Interventional

Actual Enrollment :

4 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 1, 2016

Actual Primary Completion Date :

Jun 7, 2017

Actual Study Completion Date :

Jun 7, 2017

Arms and Interventions

Arm	Intervention/Treatment
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.	Drug: Menopur Nasal versus injectable Other Names: gonadotropin Drug: Synarel nasal Other Names: GnRH agonist Drug: HCG trigger injectable Other Names: HCG Drug: Clomiphene citrate oral Other Names: Clomid Drug: Letrozole Oral Other Names: Femara
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.	Drug: Menopur Nasal versus injectable Other Names: gonadotropin Drug: Synarel nasal Other Names: GnRH agonist Drug: Clomiphene citrate oral Other Names: Clomid Drug: Letrozole Oral Other Names: Femara

Arm

Intervention/Treatment

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.

Drug: Menopur

Nasal versus injectable

Other Names:

gonadotropin

Drug: Synarel

nasal

Other Names:

GnRH agonist

Drug: HCG trigger

injectable

Other Names:

HCG

Drug: Clomiphene citrate

oral

Other Names:

Clomid

Drug: Letrozole

Oral

Other Names:

Femara

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.

Drug: Menopur

Nasal versus injectable

Other Names:

gonadotropin

Drug: Synarel

nasal

Other Names:

GnRH agonist

Drug: Clomiphene citrate

oral

Other Names:

Clomid

Drug: Letrozole

Oral

Other Names:

Femara

Outcome Measures

Primary Outcome Measures

Serum estradiol level [1 year]
serum estradiol level in pg/mL as representative of ovarian response
Ovarian follicular size [1 year]
Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response

Secondary Outcome Measures

Adverse Events That Are Related to Nasal Menopur Treatment [1 year]
whether there are any side effects

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age range: 18-45. The participant should be a woman of reproductive age, i.e., premenopausal who is healthy.
Body mass index: 19-35 kg/m2
Diagnosis of infertility: inability to conceive with unprotected intercourse after 1 year for women aged < 35 and after 6 months for women aged > 35.
Pap smear within 1 year should be normal.
Endometrial cavity will be evaluated and should be normal using hysteroscopy or saline ultrasound
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.
Semen analysis will be performed on every male partner to ensure that there are sperm to be used for IVF/ICSI.
All assessment will be performed at baseline and before initiation of any treatment.
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:

Any medical condition that interferes with the health of the participant such as uncontrolled diabetes, uncontrolled hypertension, cardiac disease, or renal disease.
Any type of malignancy.
Mental problems that could interfere with the patient's ability to conceive and take care of her baby.
Abnormal endometrial cavity that could interfere with implantation and/or carrying the pregnancy.