The Luveris In Vitro Fertilization Trial

• Sponsor: University Reproductive Associates (Other)
• Overall Status: Terminated
• CT.gov ID: NCT00889512
• Collaborator: EMD Serono (Industry)
• Enrollment: 14
• Location: 1
• Arms: 2
• Actual Duration (Months): 55
• Patients Per Site Per Month: 0.3

Study Details

Study Description

Brief Summary

The purpose of this study is to develop a new protocol using two different types of fertility drugs that is more similar to the way the hormones act in a normal menstrual cycle (period).

We are recruiting women who are trying to get pregnant through In Vitro Fertilization (IVF) who either have a high prolactin level (a hormone normally found in your blood that is produced in the brain) or have a condition known as hypothalamic amenorrhea in which one does not get regular periods due to low hormone levels.

The ovaries can be stimulated with Follicle Stimulating Hormone (FSH) alone and with FSH and Luteinizing Hormone (LH). FSH causes eggs to be made while LH causes estrogen (hormone) production. The women in this study have low hormone levels and need both FSH and LH. Luveris® (LH hormone) is a new drug approved for egg production and is used in IVF. There is no set amount of LH nor a set protocol for LH use. Therefore, we are testing this new regimen. One group of women will receive a fixed dose of LH throughout their cycle while the other will decrease the dose of FSH while at the same time increasing the LH dose which is what happens in the natural menstrual cycle.

Condition or Disease	Intervention/Treatment	Phase
Infertility; Hypothalamic Amenorrhea; Hyperprolactinemia	Drug: Luveris fixed dose; Drug: Luveris increasing dose	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Luveris® In Vitro Fertilization Trial: The Effect of Recombinant Luteinizing Hormone on Follicular Response, Oocyte Quality, and Pregnancy in In-Vitro Fertilization Treatment Cycles in Women Without Endogenous LH Activity.
• Actual Study Start Date: Apr 1, 2009
• Actual Primary Completion Date: May 1, 2013
• Actual Study Completion Date: Nov 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Luveris Fixed dose Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout.	Drug: Luveris fixed dose; Luveris 75IU daily throughout ovarian stimulation
Experimental: Luveris increasing dose Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle.	Drug: Luveris increasing dose; Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG

Outcome Measures

Primary Outcome Measures

1. The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG. [2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 38 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. 30 women under 38 years old at time of signing Informed Consent Form.

2. Evidence of hypothalamic amenorrhea (irregular menses and FSH and LH <5 mIU/mL), uncorrected hyperprolactinemia (prolactin levels 10% above the upper limit of normal) or iatrogenic hypothalamic hypogonadism secondary to GnRHa suppression.

3. In good general health off of current medications which may confound response to study medications except GnRHa (Lupron Depot).

4. Desire to seek pregnancy actively during the study period.

5. A normal uterine cavity must have been confirmed by either hysteroscopy or hydrosonogram within two years of entering the study.

6. A semen analysis on the male partner deemed adequate for IVF by the attending physician within the past year or donor sperm available for insemination.

7. Only one treatment cycle per patient will be studied.

Exclusion Criteria:

1. uncorrected thyroid disease.

2. heart disease (New York Heart Association Class II or higher).

3. a history of, or suspected cervical, endometrial, or breast cancer. A normal Pap smear result within the last 24 months will be required.

4. enrolled into other studies that require medications, limit sex, or otherwise prevent compliance with the protocol at the same time.

5. to take other medications known to affect reproduction.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Reproductive Associates	Hasbrouck Heights	New Jersey	United States	07604

Sponsors and Collaborators

• University Reproductive Associates
• EMD Serono

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Peter McGovern, MD, Director, University Reproductive Associates
• ClinicalTrials.gov Identifier: NCT00889512
• Other Study ID Numbers: 0120080358
• First Posted: Apr 29, 2009
• Last Update Posted: Aug 7, 2018
• Last Verified: Jul 1, 2018

• Additional relevant MeSH terms: Hyperprolactinemia; Infertility; Amenorrhea

Study Results

Participant Flow

Arm/Group Title	Luveris Fixed Dose	Luveris Increasing Dose
Arm/Group Description	Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation	Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
Period Title: Overall Study
STARTED	5	9
COMPLETED	5	9
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Luveris Fixed Dose	Luveris Increasing Dose	Total
Arm/Group Description	Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation	Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG	Total of all reporting groups
Overall Participants	5	9	14
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	5 100%	9 100%	14 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	5 100%	9 100%	14 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	The Primary Outcome Will be Number of Large Follicles (16 mm or Greater in Diameter) and Midsize Follicles (Greater Than 12mm But Less Than 16mm) in Both Groups on the Day of Meeting Size Criteria for hCG.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Luveris Fixed Dose	Luveris Increasing Dose
Arm/Group Description	Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation	Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
Measure Participants	5	9
Large Follicles	3	3
Midsize Follicles	4	4

Adverse Events

Time Frame	1 year
Adverse Event Reporting Description	No adverse or serious adverse events occurred
Arm/Group Title	Group A		Group B
Arm/Group Description	Participants in this arm will take Gonal F® and the same dose of Luveris® throughout the cycle. Their dose of Gonal F® will be adjusted throughout the cycle based on their response to the medication. The Luveris® dose will remain constant throughout. Luveris fixed dose: Luveris 75IU daily throughout ovarian stimulation		Patients assigned to this group will gradually reduce the Gonal F® dose while increasing the Luveris® dose during the cycle, which more closely mimics the natural menstrual cycle. Luveris increasing dose: Luveris 75IU until estradiol level reaches 250 pg/ml then increasing to 75IU BID for two days, then TID until hCG
All Cause Mortality
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/9 (0%)
Serious Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/9 (0%)
Other (Not Including Serious) Adverse Events
	Group A		Group B
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/5 (0%)		0/9 (0%)

Limitations/Caveats

Early termination leading to small numbers of subjects analyzed;

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.