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Female Urogenital Diseases and Pregnancy Complications

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Follicle Stimulating Hormone

Leuprolide

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Antineoplastic Agents, Hormonal

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone vaginal insert (Endometrin®) 100 mg starts on the day following oocyte retrieval and continues for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin beta (Follistim Pen®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

225 IU (up to 450 IU) by subcutaneous injection once per day for up to about 15 days.

Menotropin

100 mg inserted vaginally 2 or 3 times daily (BID or TID) (start on the day after oocyte retrieval) until 10 weeks gestation or confirmation of negative pregnancy test.

Progesterone vaginal insert

Follitropin beta

50 mg by intramuscular injection once per day, starting on the day after oocyte retrieval until 10 weeks gestation or confirmation of negative pregnancy test.

Progesterone in oil

Daily administration of 0.5mg of leuprolide acetate (depot formulations were not permitted) began on Day 21 following onset of menses, and then decreased to 0.25 mg when gonadotropin therapy was initiated.

leuprolide acetate

Clinical Development Support

This multicenter, randomized, open-label exploratory study will be performed in approximately 200 polycystic ovary syndrome (PCOS) but otherwise healthy females undergoing in vitro fertilization (IVF). Each study center will follow its standard practice for in vitro fertilization (IVF) within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to highly purified menotropin (Menopur®) or follitropin beta (Follistim Pen®) for stimulation and progesterone vaginal insert (Endometrin®) or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per in vitro fertilization (IVF) protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of human chorionic gonadotropin (hCG), and first serum pregnancy test) for estradiol (E2), progesterone (P4) and human chorionic gonadotropin (hCG) labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)

A Multi-Center, Randomized, Open-Label Evaluation of MENOPUR® Versus FOLLISTIM® in Polycystic Ovarian Syndrome (PCOS) Patients

A count of participants whose discontinuation was clearly documented on the study completion/termination form as cycle cancellation for risk of ovarian hyperstimulation syndrome (OHSS).

The mean number of follicles observed in both ovaries at the last transvaginal ultrasound in the stimulation phase.

The mean number of oocytes retrieved approximately 36 hours after hCG (Novarel®) administration and fertilized (by insemination or intra cytoplasmic sperm injection (ICSI)) according to site-specific procedures.

The fertilization rate for each participant was the percentage of the number of oocytes inseminated of the total number of oocytes retrieved.

The number of embryos, morulas and blastocysts transferred to the study participant on either day 3 or day 5 following fertilization. Embryos represent the earliest development stage and contain 2-8 cells.

Morulas, the next stage, continued cellular cleavage results in a 16-30 cell solid sphere. Morula further develop into blastocyst, which contains 70-100 cells in a hollow spherical shape.

The number of embryos that were not transferred but instead were frozen for future use.

Biochemical pregnancy is a positive β-hCG pregnancy test 12-14 days post embryo transfer.

Clinical pregnancy is the confirmation of the presence of intrauterine gestational sacs on pregnancy ultrasound examination.

Estradiol monitoring during fertility therapy assesses follicular growth and is useful in monitoring the treatment. Blood tests sent to a central laboratory to obtain estradiol levels.

Blood tests were sent to a central laboratory to obtain hCG levels.

Blood tests were sent to a central laboratory to obtain progesterone levels.

Number of live births resulting from the IVF process

Number of participants with adverse events (AEs) that started after first treatment. Severity used a three point scale:

mild=awareness of signs/symptoms, but no disruption of usual activity moderate=event sufficient to affect usual activity (disturbing) severe=event causes inability to work or perform usual activities (unacceptable) Relatedness to study treatment used a four point scale: unrelated, unlikely, possible, probable.

Seriousness refers to death, hospitalization, a life-threatening experience, persistent or significant disability/incapacity, or congenital anomaly.

Ferring Pharmaceuticals

Multiple events in the same system organ class for a subject are only counted once for that system organ class.

Menotropin/Progesterone Vaginal Insert

Highly purified menotropin (Menopur®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Menotropin/Progesterone in Oil

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone vaginal insert (Endometrin®) 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin Beta/Progesterone Vaginal Insert

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

Progesterone in oil 50 mg injections start on the day following oocyte retrieval and continue for a total duration of 10 weeks or until a negative pregnancy test is obtained.

Follitropin Beta/Progesterone in Oil

Total

Age, Categorical

Sex: Female, Male

Caucasian

African American

Asian

Hispanic

Other

Race/Ethnicity, Customized

Comparing Progesterone vaginal insert to Progesterone in oil within the menotropin treatments arms.

Comparing Progesterone vaginal insert to Progesterone in oil within the follitropin beta treatment group.

Intend-to-treat (ITT) population -- all randomized participants who received at least one dose of study medication

Participants With Cycle Cancellation Due to Risk of Ovarian Hyperstimulation Syndrome (OHSS) Between Weeks 1 - 3

Highly purified menotropin (Menopur®) 225 IU by subcutaneous injection once per day from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

This group combines the two treatment arms that use Highly purified menotropin (Menopur®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil.

Follitropin beta (Follistim®) 225 IU from day 1-6 of menstrual cycle. May be adjusted up to 450 IU daily for more days until human chorionic gonadotropin (hCG) criteria are met.

This group combines the two treatment arms that use Follitropin beta (Follistim®) for ovarian stimulation. This treatment is followed by luteal support using either Progesterone vaginal insert (Endometrin®) or progesterone in oil.

Follitropin Beta

Number of Follicles Observed at Day 15

Number of Oocytes Retrieved at Day 18

Percentage of Oocytes Fertilized of the Total Number of Oocytes Retrieved

Number of embryos transferred

Number of morula transferred

Number of blastocyst transferred

Number of Embryos Transferred at Three Stages of Development Before Implantation

Number of Embryos Frozen

Percentage of Participants With Biochemical Pregnancy at Approximately Day 38

Percentage of Participants With Clinical Pregnancy at Week 7

Percentage of Participants With Ongoing Pregnancy at Week 9

Estradiol Levels at Day 6

Human Chorionic Gonadotropin (hCG) Levels at Day 6

Progesterone Levels at Human Chorionic Gonadotropin (hCG) Administration

Database was locked prior to most participants giving birth.

Number of Live Births Resulting From the In Vitro Fertilization Process

With at least one adverse event

With at least one mild or moderate adverse event

With at least one severe adverse event

With at least one serious adverse event

With at least one unrelated or unlikely AE

With at least one possibly or probably related AE

Safety population all randomized and treated participants. The safety population is identical intent-to- treat (ITT) population in this study

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	NCT00805935	Polycystic Ovar... Infertility	Menotropin Progesterone va... Follitropin bet... Progesterone in... leuprolide acet...	18 Years - 42 Years	Ferring Pharmaceuticals
Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS)	NCT00805935	Polycystic Ovar... Infertility	Menotropin Progesterone va... Follitropin bet... Progesterone in... leuprolide acet...	18 Years - 42 Years	Ferring Pharmaceuticals

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