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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional IVF | Active Comparator | 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. |
|
| IVF protocol using nasal gonadotropins | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Menopur | Drug | Nasal versus injectable |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum estradiol level | serum estradiol level in pg/mL as representative of ovarian response | 1 year |
| Ovarian follicular size | Pelvic ultrasound to measure the size of each ovarian follicle as representative of ovarian response | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events That Are Related to Nasal Menopur Treatment | whether there are any side effects | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| New Hope Fertility Center | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30500132 | Result | Zhang 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. |
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will share the data upon request
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| ID | Term |
|---|---|
| D007246 | Infertility |
| ID | Term |
|---|---|
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D008596 | Menotropins |
| D006062 | Gonadotropins |
| D017274 | Nafarelin |
| D007987 | Gonadotropin-Releasing Hormone |
| D002996 | Clomiphene |
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D006065 | Gonadotropins, Pituitary |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Synarel | Drug | nasal |
|
|
| HCG trigger | Drug | injectable |
|
|
| Clomiphene citrate | Drug | oral |
|
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| Letrozole | Drug | Oral |
|
|
| D010908 | Pituitary Hormones, Anterior |
| D010907 | Pituitary Hormones |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D009479 | Neuropeptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D011506 | Proteins |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D009570 | Nitriles |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |