INFERTILITY_MR PAYAAM VOHRA NIPER MOHALI (1).ppt

LIST OF INFERTILITY DRUGS
FDA APPROVED DRUGS FOR INFERTILITY

1. Submitted by Payaam Vohra
M.S (PHARM.) PHARMACOLOGY AND TOXICOLOGY
NIPER MOHALI

2. Basic Services for Infertile Couples
Stewart GK. 2019
Association of Reproductive Health Professionals
www.arhp.org
2. Conduct appropriate diagnostic workup
3. Information on treatment options and alternatives
4. Provide resources for counseling and
emotional support
1. Educate on infertility causes and prevention
2. Conduct appropriate diagnostic workup

3. CAUSES OF MALE AND FEMALE INFERTILITY

4. Causes & Treatments for Male
Infertility
Azospermia
Surgical sterilization
Inject FSH and LH
Impaired sperm motility
Reverse vasectomy
Repair varicocele
Nelson AL, Marshall JR. 2004.

5. Endometriosis:
Treatment with Surgery
Pregnancy rates after surgery
After Stage 1 or 2Stage 3 Stage 4
Jennings VH, et al. 1998.

6. TARGET MARKET

7. End Use
Outlook
› Men
› Women
BY
APPLICATION
> In Vivo
> In Vitro
BY END-USE
> Speciality
Centres
>Hospitals
> Others
BY REGION
North America
› Europe
› Asia Pacific
› Latin America
› Middle East &
Africa
Drug Class outlook
Gonadotrphins
Hormonal agents
(SERM,Aromatase
Dopamine agonist
Others
MARKET PLAYERS
Sanofi
Merck
Novartis
Pfitzer
Merck & Co., Inc.
Ferring
Bayer
MARKET INSIGHTS OF INFERTILITY MANAGEMENT

8. Treatment Purpose Key Considerations Typical Success Rates
Medications
Clomiphene Citrate (Clomid) Stimulates ovulation Effective for women with ovulation disorders10-12% per cycle; higher with multiple cycles
Letrozole (Femara) Induces ovulation Often used for women with PCOS 12-15% per cycle
Gonadotropins Stimulates ovaries to produce multiple folliclesRequires monitoring; risk of multiple pregnancies15-20% per cycle
Metformin Improves insulin resistance in PCOS patientsPrimarily for women with insulin resistance or PCOSVaries; improves cycle regularity
Herbs Balances hormones or improves reproductive healthUsed for prolactin-related ovulation issues Varies depending on underlying cause
Dietary supplements Folic acid, vitamin D, and coenzyme Q10
Needs individualized assessment; potential interactionsVitex, Maca, or Ginseng,
Laparoscopy Removes endometriosis, fibroids, adhesionsMinimally invasive; short recovery time Varies by condition; up to 50%
Hysteroscopy Corrects uterine abnormalities Outpatient procedure; quick recovery Varies by condition; up to 40%
Tubal Surgery Repairs blocked or damaged fallopian tubesDepends on extent of damage; alternative to IVF20-40% over two years post-surgery
Assisted Reproductive Technologies (ART)
In Vitro Fertilization (IVF) Fertilizes eggs outside the body and transfers embryosInvasive; expensive; multiple cycles may be needed20-40% per cycle, varying by age
Intracytoplasmic Sperm Injection (ICSI) Injects sperm directly into an egg Often used for severe male infertility Similar to IVF success rates
Frozen Embryo Transfer (FET) Transfers previously frozen embryos
Less invasive than fresh IVF; thawing can affect
quality
30-40% per transfer
Egg Donation Uses eggs from a donor Suitable for women with poor ovarian reserve50-60% per cycle
Sperm Donation Uses donor sperm for fertilization Suitable for severe male infertility or single womenDepends on method (IUI or IVF)
Intrauterine Insemination (IUI) Places sperm directly into the uterus Less invasive; often combined with ovulation induction10-20% per cycle
Lifestyle and Dietary Adjustments
Weight Management Achieves optimal weight for fertility Impacts ovulation and sperm quality Varies; can significantly improve outcomes
Smoking and Alcohol Cessation Reduces negative impact on fertility Improves overall reproductive health Varies; improves success rates
Alternative and Complementary Therapies
Acupuncture Improves blood flow to reproductive organsMay complement other treatments; evidence is mixedVaries; supportive rather than primary
Mind-Body Practices Reduces stress and promotes well-being May improve overall fertility indirectly Supportive; no direct success rate
Male Fertility Treatments
Medications Treats hormonal imbalances or infections Depends on underlying cause; effectiveness variesVaries
Surgery
Repairs physical blockages or conditions like
varicocele
Depends on severity of condition 20-40% improvement in pregnancy rates
Lifestyle Changes Enhances sperm quality Includes diet, stress reduction, and toxin avoidanceVaries
ART Techniques (e.g., ICSI) Assists in cases of severe male infertilityOften used when sperm quality is very poorSimilar to IVF/ICSI success rates
Pre-implantation Genetic Testing (PGT) Tests embryos for genetic conditions before transferAdds cost; may reduce miscarriage rates Improves pregnancy rates in older women
Fertility Preservation
Egg or Sperm Freezing Preserves gametes for future use Useful for cancer patients or delaying childbearingVaries; dependent on age at freezing
Embryo Freezing Stores embryos for future use Commonly used in IVF cycles Varies; similar to fresh embryo transfer
Surrogacy and Gestational Carriers
Traditional Surrogacy Uses surrogate’s egg for conception Legal and emotional complexities Varies; dependent on surrogate's fertility
Gestational Surrogacy Uses intended parents’ or donors' embryosExpensive; legal and ethical considerations50-60% per cycle

9. MFG COMPANIES INVOVLED FOR INFERTILITY
Medication Purpose Common Brand Names Manufacturing Companies
Clomiphene Citrate
(Clomid)
Stimulates ovulation Clomid, Serophene Sanofi, Merck KGaA
Letrozole Induces ovulation Femara Novartis
Gonadotropins
-FSH (Follicle-Stimulating
Hormone)
Stimulates the growth of
ovarian follicles
Gonal-F, Follistim AQ
Merck Serono, Ferring
Pharmaceuticals
-LH (Luteinizing Hormone)
Triggers ovulation and
supports corpus luteum
function
Luveris, Menopur
Merck Serono, Ferring
Pharmaceuticals
-hCG (Human Chorionic
Gonadotropin)
Triggers final maturation of
the eggs
Ovidrel, Pregnyl, Novarel
Merck Serono, Organon,
Ferring Pharmaceuticals
Metformin
Improves insulin resistance in
PCOS patients
Glucophage, Fortamet
Bristol-Myers Squibb, Teva
Pharmaceuticals
Dopamine Agonists Lowers prolactin levelsDostinex, Parlodel Pfizer, Novartis
Other Medications
-Progesterone
Supports luteal phase and
early pregnancy
Endometrin, Crinone
Ferring Pharmaceuticals,
Merck Serono
-Bromocriptine Reduces prolactin levelsParlodel Novartis
Other Supportive
Medications
-Aspirin
May improve blood flow to
the uterus
Bayer Aspirin Bayer AG
-Low Molecular Weight
Heparin (LMWH)
Reduces risk of blood clots in
patients with thrombophilia
Lovenox Sanofi
Ke

10. Main Causes of Female Infertility
Nelson AL, Marshall JR. 2024.

11. Treatments for Female Infertility
•Maintain normal body weight
•Clomiphene
•Metformin
•Gonadotropin therapies
•Laparoscopic ovarian drilling
Gizelle,Andreas ,et al. 2023.
more…

12. Treatments for Female Infertility
(continued)
•In vitro fertilization
•With or without salpingectomy
•Tuboplasty (tubal ligation
reversal)
Elvish, George et al. 2022.
more…

13. Treatments for Female Infertility
(continued)
•Laparoscopic ablation
•Intrauterine insemination with
controlled hyperstimulation
•In vitro fertilization
Nelson AL, Marshall JR. 2004.

14. Ovulation-Inducing Drugs:
Clomiphene
•Chemically stimulates pituitary gland to
produce hormones that trigger ovulation
process
•Usual dosage: 50 mg/day for 5 days
•Numerous side effects
•May not be appropriate for patients with:
▪Large fibroid tumors
▪Ovarian cysts
▪Liver problems
Harkness C. The Infertility Book. 2022.
more…

15. Ovulation-Inducing Drugs:
Bromocriptine
•Reduces production of prolactin hormone
•Dosage: 2.5 mg 1–3 times/day
•Some side effects
•May not be appropriate for patients with
pituitary tumors >1 cm
Karley.c. The Infertility Mayfair. 2012.

16. Ovulation-Inducing Drugs
•Human Menopausal Gonadotropins (hMG)
•Follicle-Stimulating Hormone (FSH)
▪Stimulate ovary to develop follicles
▪75–150 IU/day (with hCG)
▪20–40% possibility of multiple births
▪May not be appropriate in cases of pituitary
tumor, ovarian cysts
Harkness C. The Infertility Book. 1992.
more…

17. Ovulation-Inducing Drugs (continued)
Gonadotropin-Releasing Hormone (GnRH)
•Triggers normal pituitary hormonal activity so
ovulation can occur
•Effective in women with hypothalamic
amenorrhea
•No known physical side effects
•Ovulation pump administers injections every
90 minutes
•User must carry pump with attached IV tubing
for 1–2 weeks or until ovulation occurs
Harkness C. The Infertility Book. 1992.

18. Polycystic Ovarian Disease:
Treatment
Ovulation induction
•Clomiphene
•HMG, FSH, GnRH
•Insulin sensitizers (e.g. metformin,
rosiglitazone)
Jennings VH, et al. 1998.

19. ART Treatments for Infertility
American Society for Reproductive Medicine. 2021.
American Society for Reproductive Medicine. 2023.
IVF with embryo transfer
Gamete intrafallopian transfer (GIFT)
Zygote intrafallopian transfer (ZIFT)
Cryopreservation
Intracytoplasmic sperm injection (ICSI)

20. IVF with Embryo Transfer
Clapp DN. 2022.
Egg and sperm are retrieved from couple,
donor(s), or both
Combined in a petri dish, incubated for
2–5 days
If fertilization and cleavage occurs,
embryo is transferred through a catheter
to uterus

21. Gamete Intrafallopian Transfer
(GIFT)
Samuel, et al. 2023.
Oocytes retrieved via laparoscopy
Oocytes and sperm placed in same catheter
Injected directly into the fallopian tube via
laparoscopy
Embryo travels through the fallopian tube
to the uterus for implantation

22. Zygote Intrafallopian Transfer (ZIFT)
Combines techniques used in IVF and GIFT
Clapp DN. 2022.
Ova are placed in a petri dish with sperm
If fertilization occurs, the zygote:
•Is injected into fallopian tube
•Travels through tube to uterus
•Implants in uterus

23. Cryopreservation
Sperm or embryos are preserved by freezing
for replacement in subsequent cycles
Clapp DN. 2022.
Photo source: http://www.dcmsonline.org

24. Intracytoplasmic Sperm Injection
(ICSI)
•A single sperm is
injected directly into the
cytoplasm of the oocyte
•Increases probability of
fertilization
American Society for Reproductive Medicine. 2004.
Photo source: www.fertilitycentre.ca

25. ART Options for Same-Sex Couples
•Combination of their own
and donor sperm and
eggs through IVF
•Surrogacy
•Can parent biological
children
Bateman S. 2004.

26. THANK YOU